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

Registration Number
NCT01641081
Lead Sponsor
AstraZeneca
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
174
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Experimental 1Formoterol Fumarate in the Pressair DPI, Low DoseFormoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
PlaceboPlaceboDose matched placebo
Active Comparator 1Foradil Aerolizer, Low DoseForadil Aerolizer, Low Dose
Active Comparator 2Foradil Aerolizer, High DoseForadil Aerolizer, High Dose
Experimental 2Formoterol Fumarate in the Pressair DPI, High DoseFormoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment

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

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment

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

Trial Locations

Locations (29)

Forest Investigative Site 909

🇺🇸

Phoenix, Arizona, United States

Forest Investigative Site 2066

🇺🇸

Encinitas, California, United States

Forest Investigative Site 1624

🇺🇸

Los Angeles, California, United States

Forest Investigative Site 1995

🇺🇸

Mission Viejo, California, United States

Forest Investigative Site 1347

🇺🇸

San Jose, California, United States

Forest Investigative Site 1996

🇺🇸

Centennial, Colorado, United States

Forest Investigative Site 1137

🇺🇸

Colorado Springs, Colorado, United States

Forest Investigative Site 1998

🇺🇸

Denver, Colorado, United States

Forest Investigative Site 2047

🇺🇸

Tampa, Florida, United States

Forest Investigative Site 1536

🇺🇸

Louisville, Kentucky, United States

Scroll for more (19 remaining)
Forest Investigative Site 909
🇺🇸Phoenix, Arizona, United States

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