Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma

Study Overview
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Brief Summary
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The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma. This study will include a screening visit followed by a 4 month treatment period.

Official Title
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Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover Study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients With Mild to Moderate Asthma.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Formoterol Fumarate in the Pressair DPI, Low Dose
* Drug: Formoterol Fumarate in the Pressair DPI, High Dose
* Drug: Foradil Aerolizer, Low Dose
* Drug: Foradil Aerolizer, High Dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusions: Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as defined in the GINA Guidelines) which is unlikely to exacerbate during the study (e.g., due to seasonal allergen exposure). Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30 days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the use of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1. Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of predicted for age, height, and gender using NHANES III (NHANES 2010) when bronchodilator medications have been withheld the appropriate length of time per the List of Concomitant Medications (Appendix III) Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after the administration of 360 µg of albuterol. Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the qualifying FEV1 at Visit 1 Exclusions: Patients with any clinically significant respiratory conditions other than mild to moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung disease Patients with a severe asthma exacerbation requiring hospitalization in the previous 12 months Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for at least 6 hours prior to visit

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose | Drug: Formoterol Fumarate in the Pressair DPI, Low Dose<br>* Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days<br>|
| Experimental: Experimental 2<br>Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose | Drug: Formoterol Fumarate in the Pressair DPI, High Dose<br>* Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days<br>|
| Active Comparator: Active Comparator 1<br>Foradil Aerolizer, Low Dose | Drug: Foradil Aerolizer, Low Dose<br>* Foradil Aerolizer 12 micrograms, twice a day for 14 days<br>* Other names: Formoterol;|
| Active Comparator: Active Comparator 2<br>Foradil Aerolizer, High Dose | Drug: Foradil Aerolizer, High Dose<br>* Foradil Aerolizer 24 micrograms, twice per day for 14 days<br>* Other names: Formoterol;|
| Placebo Comparator: Placebo<br>Dose matched placebo | Drug: Placebo<br>* Placebo in the Pressair for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14) | AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals | Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1) | AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals | Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment |