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A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479412
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : June 23, 2017
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled, multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma.

Condition or disease Intervention/treatment Phase
Asthma Efficacy Safety Drug: 800 μg AZD7594 once daily Drug: 250 µg AZD7594 once daily Drug: 58 µg AZD7594 once daily Drug: Placebo once daily Drug: Salbutamol Phase 2

Detailed Description:

This is a randomized, double-blind, multiple dosing (14 ± 1 days), placebo-controlled, incomplete block crossover, multi-center study to assess efficacy and safety of 3 dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma.

This multi-center study will be conducted at multiple sites in Europe. It is planned that approximately 48 patients with mild to moderate asthma will be randomized into the study


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A RANDOMIZED, DOUBLE BLIND, MULTIPLE DOSING (14 DAYS), PLACEBO-CONTROLLED, INCOMPLETE BLOCK CROSSOVER, MULTI CENTER STUDY TO ASSESS EFFICACY AND SAFETY OF THREE DOSE LEVELS OF AZD7594, GIVEN ONCE DAILY BY INHALATION, IN PATIENTS WITH MILD TO MODERATE ASTHMA
Actual Study Start Date : June 25, 2015
Actual Primary Completion Date : February 8, 2016
Actual Study Completion Date : February 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Sequence 1
Placebo once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3
Drug: 250 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Medium dose of AZD7594

Drug: 58 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Low dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 2
Placebo once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3
Drug: 800 μg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: High dose of AZD7594

Drug: 250 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Medium dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 3
Placebo once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3
Drug: 800 μg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: High dose of AZD7594

Drug: 58 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Low dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 4
58 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3
Drug: 800 μg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: High dose of AZD7594

Drug: 58 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Low dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 6
250 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3
Drug: 250 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Medium dose of AZD7594

Drug: 58 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Low dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 8
800 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3
Drug: 800 μg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: High dose of AZD7594

Drug: 250 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Medium dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 5
58 µg AZD7594 once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3
Drug: 800 μg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: High dose of AZD7594

Drug: 58 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Low dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 7
250 µg AZD7594 once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3
Drug: 250 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Medium dose of AZD7594

Drug: 58 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Low dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication

Experimental: Sequence 9
800 µg AZD7594 once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3
Drug: 800 μg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: High dose of AZD7594

Drug: 250 µg AZD7594 once daily
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Medium dose of AZD7594

Drug: Placebo once daily
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Other Name: Placebo

Drug: Salbutamol
Inhalation as needed
Other Name: Rescue medication




Primary Outcome Measures :
  1. Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15 [ Time Frame: On Day 1 (pre-dose) and on Day 15 in each period ]
    Comparison of the efficacy of AZD7594 in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14) with placebo


Secondary Outcome Measures :
  1. Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 8 [ Time Frame: On Day 1 (pre-dose) and on Day 8 in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 8

  2. Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 15 [ Time Frame: On Day 1 (pre-dose) and on Day 15 in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 15

  3. Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 8 [ Time Frame: On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)

  4. Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 15 [ Time Frame: On Day 1 (pre-dose) and on Day 15 (pre-dose) in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14)

  5. Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 8 [ Time Frame: On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)

  6. Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Peak Expiratory Flow (mPEF) Before Administration Over the Treatment Period [ Time Frame: Every morning at pre-dose from Day 1 to Day 15 ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in morning peak expiratory flow (mPEF) before administration of the investigational medicinal product (IMP) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as mPEF with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).

  7. Efficacy of AZD7594 by Assessment of the Change From Baseline in Evening Peak Expiratory Flow (ePEF) Before Administration Over the Treatment Period [ Time Frame: Every evening from Day 1 to Day 14 in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in evening peak expiratory flow (ePEF) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as ePEF together with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).

  8. Efficacy of AZD7594 by Assessment of the Change From Baseline in Average Daily Use of Rescue Salbutamol Over the Treatment Period [ Time Frame: Every day from Day 1 to Day 15 (from evening of Day 1 to morning of Day 15) ]
    The efficacy of AZD7594 was assessed in terms of change from baseline in average daily use of salbutamol (each morning and evening) in each treatment period.

  9. Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 15 in Asthma Control Questionnaire-5 [ Time Frame: At baseline and on Day 15 in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a higher score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.

  10. Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 8 in Asthma Control Questionnaire-5 [ Time Frame: At baseline and on Day 8 in each period ]
    The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a lower score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.

  11. Efficacy of AZD7594 by Assessment of Night-time Awakenings [ Time Frame: At baseline and from Day 2 to Day 15 in each period ]
    The efficacy of AZD7594 was assessed in terms of change in nighttime awakenings in each treatment period. The patients were asked to answer 'Yes' or 'No' to the question of "Did your asthma cause you to wake up last night?". If yes, the number and percentage of days that had a night-time awakening were determined for each of the study periods.

  12. Efficacy of AZD7594 by Assessment of Daily Symptom Score [ Time Frame: At baseline and from Day 1 to Day 14 in each period ]
    The efficacy of AZD7594 was assessed in terms of change in daily symptom score from baseline to average of treatment period post dose (Day 1-14) in each treatment period. Severity scores for asthma symptoms were recorded twice daily, once in the morning and once in the evening with the scoring system of 0-no asthma symptoms, 1-toleratable asthma symptoms, 2-discomfort asthma symptoms with normal activities (or with sleep) and 3-asthma symptoms with impaired normal activities (or to sleep).

  13. Efficacy of AZD7594 by Assessment of Asthma Control Days [ Time Frame: At baseline and from Day 1 to Day 14 post-dose in each period ]
    The efficacy of AZD7594 was assessed in terms of amount of asthma control days in each treatment period. An asthma control day was defined as a day with asthma symptom score = 0, a night with no awakenings due to asthma symptoms and a day with no use of rescue medication. A given calendar day was defined as an asthma control day if it fulfills the criteria for a symptom-free day and for a rescue medication-free day

  14. Number of Participants With Adverse Events [ Time Frame: From Screening to Follow-up (these two examinations are up to 165 days apart) ]
    Assessment of safety and tolerability of three dose levels of AZD7594 in participants with mild to moderate asthma. IP referred to investigational product.

  15. Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Cmax of AZD7594 [ Time Frame: On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose) ]
    Comparison of Cmax (maximum observed plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)

  16. Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of AUC(0-4) of AZD7594 [ Time Frame: On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose) ]
    Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).

  17. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax,ss of AZD7594 [ Time Frame: On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose) ]
    Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)

  18. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24) of AZD7594 [ Time Frame: On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose) ]
    Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)

  19. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-last) of AZD7594 [ Time Frame: On Day 1 and Day 14 in each period (in participants with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose) ]
    Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (Day 1 and Day 14)) of AZD7594 (i.e. in participants with intensive pharmacokinetic assessments)

  20. Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Tmax of AZD7594 [ Time Frame: On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose) ]
    Comparison of tmax (time to reach maximum plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)

  21. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Tmax,ss of AZD7594 [ Time Frame: On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose) ]
    Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)

  22. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cavg,ss of AZD7594 [ Time Frame: On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose) ]
    Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)

  23. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax/D of AZD7594 [ Time Frame: On Day 1 in each period ]
    Comparison of Cmax/D (dose-normalized Cmax) of AZD7594

  24. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24)/D of AZD7594 [ Time Frame: On Day 14 in each period ]
    Comparison of AUC(0-24)/D (dose-normalized AUC(0-24)) of AZD7594

  25. Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmin of AZD7594 [ Time Frame: On Day 14 at pre-dose in each period ]
    Comparison of steady-state minimum (pre-dose) concentration (Cmin) of AZD7594 in each treatment period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index of 18 to 35 kg/m2
  • Men and women 18 to 75 years of age, inclusive
  • Patients need to be non-smokers or ex-smokers (quit ≥ 6 months before the Visit 1) with total smoking history of < 10 pack years
  • Documented clinical diagnosis of asthma for ≥ 6 months before the Visit 1
  • Patients on low-dose inhaled corticosteroids (ICS) (equivalent of budesonide ≤ 400 μg per day) or low-dose ICS/long-acting β-2 agonist (LABA), or not on any inhaled steroids, or patients on montelukast
  • Patients should be controlled on low dose budesonide during the first 14 ±2 days of Run-in Part 1, i.e., they need to have ACQ-5 of ≤ 1.5 at Visit 2.
  • Prebronchodilator FEV1 at Visit 3 should be between 40% and 90% of predicted (mean of 2 predose measurements taken 30 minutes apart).
  • All patients need to have FeNO concentrations of ≥ 25 parts per billion at Visit 3
  • Demonstrate the ability to use the study inhalation device properly
  • Women must be of nonchildbearing potential defined as meeting 1 of the following criteria:

    • Permanently or surgically sterilized, including hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
    • Postmenopausal; aged ≤ 50 years and have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range
    • Postmenopausal; aged > 50 years and have been amenorrheic for 12 months or more, following cessation of all exogenous hormonal treatments
  • Male patients should be willing to use a condom to prevent pregnancy and exposure of a female partner to AZD7594 and should refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.

Exclusion Criteria:

  • Known or suspected hypersensitivity to the IMPs or excipients, including lactose
  • Systemic steroid use in the 6 weeks before Visit 1
  • Any active disease other than asthma
  • Patients on medium to high-dose ICS (equivalent of budesonide > 400 μg per day) or on inhaled anticholinergic combination within the 6 weeks prior to Visit 1
  • Compliance with the eDiary of at least 80% of the days is expected in both Run-in and Treatment Periods. Patients with < 80% eDiary compliance during Run-in Periods would not be randomized
  • Treatment with biologicals such as monoclonal antibodies or chimeric biomolecules including omalizumab within 6 months or 5 half-lives before Visit 1, whichever is longer
  • History or clinical suspicion of any clinically relevant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study, or any other safety concerns in the opinion of the Investigator
  • ACQ-5 ≥ 3 at any time between Visits 1 and 3
  • Any contraindication against the use of vagolytic or sympathomimetic drugs as judged by the Investigator.
  • Patients with hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV)
  • Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1
  • Pregnant woman or a nursing mother
  • Suspicion of Gilbert's syndrome
  • Vulnerable persons (e.g., persons kept in detention)
  • ACQ-5 of ≥ 3 or daily rescue use of ≥ 12 puffs for ≥ 3 consecutive days during the enrollment period
  • Hypersensitivity to the active substance or to any of the excipients of the Run-in medication (i.e., budesonide)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479412


Locations
Layout table for location information
Bulgaria
Research Site
Sofia, Bulgaria, 1612
Germany
Research Site
Berlin, Germany, 10717
Research Site
Berlin, Germany, 10969
Research Site
Berlin, Germany, 14050
Research Site
Frankfurt, Germany, 60596
Research Site
Großhansdorf, Germany, 22927
Research Site
Hamburg, Germany, 20354
Research Site
Hamburg, Germany, 22143
Research Site
Lübeck, Germany, 23552
Research Site
Wiesbaden, Germany, 65187
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: Rainard Fuhr, Dr. med. PAREXEL International GmbH, Berlin, Germany
Principal Investigator: Ulrike Westerhausen, Dr. Pneumologisches Studienzentrum, Berlin, Germany
Principal Investigator: Oliver Kornmann, Dr. IKF Pneumologie GmbH, Frankfurt, Germany
Principal Investigator: Jutta Beier, Dr. med. Insaf GmbH, Wiesbaden, Germany
Principal Investigator: Christine Grigat, Dr. Clinical Research Hamburg GmbH, Hamburg, Germany
Principal Investigator: Andrea Ludwig-Sengpiel, Dr. KLB Gesundheitsforschung Lübeck GmbH, Lübeck, Germany
Principal Investigator: Dirk Skowasch, Prof. University hospital of Bonn, Department of Internal Medicine II, Bonn, Germany
Principal Investigator: Anne-Marie Kirsten, Dr. Pneumologisches Forschungsinstitut an der LungenClinic Großhansdorf, Großhansdorf, Germany
Principal Investigator: Tanya Kralimarkova, Dr. COMAC Medical Ltd., Sofia, Bulgaria
Principal Investigator: Anneliese Linnhoff, Dr. med. Praxis für Lungen- und Bronchialheilkunde, Allergologie und Umweltmedizin
Principal Investigator: Margret Jandl, Dr. Hamburger Institut für Therapie Forschung GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02479412     History of Changes
Other Study ID Numbers: D3741C00003
2014-005306-37 ( EudraCT Number )
First Posted: June 24, 2015    Key Record Dates
Results First Posted: June 23, 2017
Last Update Posted: February 15, 2018
Last Verified: August 2017
Keywords provided by AstraZeneca:
Mild to moderate asthma
FEV1
efficacy
safety
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action