Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01348139
First received: May 3, 2011
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.


Condition Intervention Phase
Asthma
Drug: AZD3199
Other: AZD3199 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre, 6-way Crossover, Single-dose, Phase IIa Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 Administered Via Single Inhalation Device Compared to AZD3199 Administered Via Turbuhaler™ Inhaler in Patients With Asthma

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Emax: Maximum Value of FEV1 for Every Treatment Visits [ Time Frame: 0-24 hrs ] [ Designated as safety issue: No ]
    Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.

  • E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit [ Time Frame: 22-26 hrs. ] [ Designated as safety issue: No ]
    Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.


Secondary Outcome Measures:
  • tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit [ Time Frame: 0 - 24 hrs. ] [ Designated as safety issue: No ]
    Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.

  • E5min: The Value of FEV1 at 5 Min for Every Treatment Visit. [ Time Frame: FEV1 at 5 min ] [ Designated as safety issue: No ]
    Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.

  • E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit [ Time Frame: 0 - 24 hrs ] [ Designated as safety issue: No ]
    Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.

  • Emax: Maximum Value of Pulse for Every Treatment Visits [ Time Frame: 0 - 4 hrs. ] [ Designated as safety issue: No ]
    Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.

  • E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit [ Time Frame: 0 - 4 hrs. ] [ Designated as safety issue: No ]
    Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.

  • Cmax: Maximum Plasma Concentration [ Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. ] [ Designated as safety issue: No ]
    Maximum plasma concentration (Cmax) for AZD3199 doses

  • AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC), [ Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses

  • Tmax:Time to Maximum Plasma Concentration [ Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. ] [ Designated as safety issue: No ]
    Time to maximum plasma concentration (tmax), for AZD3199 doses

  • t1/2 :Terminal Half-life [ Time Frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. ] [ Designated as safety issue: No ]
    Terminal half-life (t1/2),for AZD3199 doses


Enrollment: 39
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD3199 800 µg inhaled via single inhaler device (SID), single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Experimental: 2
AZD3199 880 µg inhaled via SID, single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Experimental: 3
AZD3199 1400 µg inhaled via SID, single dose
Drug: AZD3199
Inhaled via single inhaler device (SID)
Experimental: 4
AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose
Drug: AZD3199
Inhaled via Turbuhaler inhaler
Experimental: 5
AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose
Drug: AZD3199
Inhaled via Turbuhaler inhaler
Placebo Comparator: 6
Placebo inhaled via Turbuhaler inhaler and SID, single dose
Other: AZD3199 Placebo
Inhaled via Turbuhaler inhaler and SID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of signed and dated written informed consent prior to any study specific procedures
  • Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method throughout the study.
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to study start
  • A history of asthma for at least 6 months.
  • Body Mass Index (BMI) 19-30 kg/m2

Exclusion Criteria:

  • Significant 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 result of the study, or the patient's ability to participate in the study
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to β2-agonists in general or to AZD3199 and/or excipients
  • Prolonged QTcF > 450 msec or shortened QTcF <340 msec
  • History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348139

Locations
Sweden
Research Site
Göteborg, Sweden
Research Site
Luleå, Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01348139     History of Changes
Other Study ID Numbers: D0570C00011, 2011-000133-37
Study First Received: May 3, 2011
Results First Received: January 28, 2013
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Asthma
patients
lung function

Additional relevant MeSH terms:
Respiratory Aspiration
Asthma
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014