Dose-Ranging Study of A006 DPI, in Adult Asthma Patients

Study Overview
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Brief Summary
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This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.

Official Title
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Phase II Study Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Cross-over and Dose-ranging Study of A006 DPI, Albuterol Inhalation Powder, in Adult Asthma Patients

Conditions
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Asthma, Bronchospasm

Intervention / Treatment
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* Drug: albuterol inhalation powder
* Drug: albuterol inhalation powder
* Drug: albuterol inhalation powder
* Drug: albuterol inhalation powder
* Drug: Placebo
* Drug: albuterol inhalation aerosol
* Drug: albuterol inhalation aerosol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control; Must demonstrate response to beta 2 agonist by Reversing; Must demonstrate ability to use DPI; Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; Additional Criteria Exclusion Criteria: Smoking history of ≥ 10 pack-years, or having smoked within 6 months; Upper respiratory tract infections Asthma exacerbations; Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®; Use of prohibited drugs or failure to observe the drug washout restrictions; Having been on other clinical drug/device studies in the last 30 days; Other Criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T1<br>A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation | Drug: albuterol inhalation powder<br>* A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation<br>|
| Experimental: T2<br>A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation | Drug: albuterol inhalation powder<br>* A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation<br>|
| Experimental: T3<br>A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations | Drug: albuterol inhalation powder<br>* A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations<br>|
| Experimental: T4<br>A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations | Drug: albuterol inhalation powder<br>* A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations<br>|
| Placebo Comparator: P<br>Placebo, 2 inhalations | Drug: Placebo<br>* placebo, lactose inhalation carrier<br>|
| Active Comparator: R1<br>Proventil 90 mcg/inhalation, 2 inhalations | Drug: albuterol inhalation aerosol<br>* albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations<br>* Other names: Proventil;|
| Active Comparator: R2<br>Proventil 90 mcg/inhalation, 4 inhalations | Drug: albuterol inhalation aerosol<br>* albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations<br>* Other names: Proventil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control. | 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Effect | Time to onset of bronchodilator effect | 0 to 360 minutes | 
| Peak Response | peak bronchodilator response | 0 - 360 minutes | 
| Duration | Duration of effect | 0 - 360 minutes | 
| Response Rate | Bronchodilatory Response Rate | 0 - 360 minutes | 
| Hand Tremor | Evaluation of hand tremor | within 5 min. prior to dosing and 50 and 360 min post-dose. | 
| Vital Signs | Pulse, heartrate, respirations, blood pressure | within 15 min. prior to dosing, and 30, 90 and 360 min post-dose. | 
| 12 lead ECG | 12-lead ECG for routine and QT/QTc evaluations | within 15 min. prior to dosing and at 50 and 360 min postdose. | 
| Blood Work | Collect blood samples ( 5 mL) for serum glucose and K+ tests | within 15 min. prior to dosing, and 30 and 120 min. postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, bronchospasm, COPD, chronic respiratory disease