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Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients

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ClinicalTrials.gov Identifier: NCT01425801
Recruitment Status : Completed
First Posted : August 30, 2011
Results First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: LAS100977 Drug: Reference Drug: Placebo Phase 2

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 Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm #2
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose
Experimental: Arm #3
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose
Experimental: Arm #4
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose
Active Comparator: Arm #5
Single dose, double blind treatment period
Drug: Reference
Pressurized inhalation suspension, Once daily , single dose
Placebo Comparator: Arm #6
Single dose, double blind treatment period
Drug: Placebo
Dry powder inhalation or Pressurized inhalation
Experimental: Arm #1
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose



Primary Outcome Measures :
  1. Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.


Secondary Outcome Measures :
  1. Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.

  2. Peak Forced Expiratory Volume in One Second (FEV1) [ Time Frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose ]
    The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.

  3. Time to Peak Forced Expiratory Volume in One Second (FEV1) [ Time Frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose ]
    The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.

  4. Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline and +23 h and +24 h post-dose ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  5. Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24/24h at Day 1 [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h ]
    FEV1 was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  6. Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  7. Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  8. Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  9. Change From Baseline in Peak Forced Vital Capacity (FVC) [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  10. Peak Forced Vital Capacity (FVC) [ Time Frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h ]
    The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  11. Time to Peak Forced Vital Capacity (FVC) [ Time Frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h ]
    The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  12. Change From Baseline to Trough Forced Vital Capacity (FVC) [ Time Frame: Baseline and +23 h +24 h post-dose ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  13. Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24/24h at Day 1 [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h ]
    FVC was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  14. Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

  15. Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint [ Time Frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h ]
    Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male and female patients aged 18-70 years (both included).
  2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
  3. Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
  4. FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
  5. Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
  6. Patients on a stable dose and regimen

Exclusion Criteria:

  1. Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
  2. Patients diagnosed with COPD.
  3. Recent Respiratory tract infections within 6 weeks before Screening Visit.
  4. Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
  5. Clinically significant respiratory conditions.
  6. Clinically significant cardiovascular conditions.
  7. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
  8. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
  9. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.

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): NCT01425801


Locations
Germany
Almirall Investigational Sites#6
Berlin, Germany, 10117
Almirall Investigational Sites#4
Berlin, Germany, 14050
Almirall Investigational Sites#1
Berlin, Germany, 14057
Almirall Investigational Sites#3
Frankfurt, Germany, 60596
Almirall Investigational Sites#2
Grosshansdorf, Germany, 22927
Almirall Investigational Sites#8
Hamburg, Germany, 20249
Almirall Investigational Sites#5
Wiesbaden, Germany, 65187
United Kingdom
Almirall Investigational Sites#2
London, United Kingdom, W1G 8HT
Almirall Investigational Sites#1
Manchester, United Kingdom, M3 9QZ
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carol Astbury, PhD AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01425801     History of Changes
Other Study ID Numbers: M/100977/202
First Posted: August 30, 2011    Key Record Dates
Results First Posted: January 26, 2018
Last Update Posted: January 26, 2018
Last Verified: June 2017

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases