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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Formoterol Fumarate in the Pressair DPI, Low Dose; Drug: Placebo; Drug: Foradil Aerolizer, Low Dose; Drug: Foradil Aerolizer, High Dose; Drug: Formoterol Fumarate in the Pressair DPI, High Dose

• 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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-16
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Disposition First Submitted: 2013-02-13
• Disposition First Submitted QC: 2013-02-13
• Disposition First Posted: 2013-02-18
• Results First Submitted: 2016-10-27
• Results First Submitted QC: 2016-10-27
• Results First Posted: 2016-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-02-28

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

Group	Intervention	Description
Experimental 1	Formoterol Fumarate in the Pressair DPI, Low Dose	Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
Placebo	Placebo	Dose matched placebo
Active Comparator 1	Foradil Aerolizer, Low Dose	Foradil Aerolizer, Low Dose
Active Comparator 2	Foradil Aerolizer, High Dose	Foradil Aerolizer, High Dose
Experimental 2	Formoterol Fumarate in the Pressair DPI, High Dose	Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 1333; 🇺🇸 Baltimore, Maryland, United States

Forest Investigative Site 909; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 1347; 🇺🇸 San Jose, California, United States

Forest Investigative Site 1609; 🇺🇸 Bellevue, Nebraska, United States

Forest Investigative Site 1998; 🇺🇸 Denver, Colorado, United States

Forest Investigative Site 1624; 🇺🇸 Los Angeles, California, United States

Forest Investigative Site 1332; 🇺🇸 El Paso, Texas, United States

Forest Investigative Site 2041; 🇺🇸 Minneapolis, Minnesota, United States

Forest Investigative Site 2043; 🇺🇸 Medford, Oregon, United States

Forest Investigative Site 1999; 🇺🇸 Skillman, New Jersey, United States

Forest Investigative Site 1176; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 1134; 🇺🇸 Canton, Ohio, United States

Forest Investigative Site 1155; 🇺🇸 Dallas, Texas, United States

Forest Investigative Site 2066; 🇺🇸 Encinitas, California, United States

Forest Investigative Site 1996; 🇺🇸 Centennial, Colorado, United States

Forest Investigative Site 1995; 🇺🇸 Mission Viejo, California, United States

Forest Investigative Site 2047; 🇺🇸 Tampa, Florida, United States

Forest Investigative Site 1431; 🇺🇸 North Dartmouth, Massachusetts, United States

Forest Investigative Site 1153; 🇺🇸 Raleigh, North Carolina, United States

Forest Investigative Site 1370; 🇺🇸 New Braunfels, Texas, United States

Forest Investigative Site 2025; 🇺🇸 Charleston, South Carolina, United States

Forest Investigative Site 1137; 🇺🇸 Colorado Springs, Colorado, United States

Forest Investigative Site 1599; 🇺🇸 Saint Louis, Missouri, United States

Forest Investigative Site 1536; 🇺🇸 Louisville, Kentucky, United States

Forest Investigative Site 1806; 🇺🇸 Cincinnati, Ohio, United States

Forest Investigative Site 1580; 🇺🇸 Portland, Oregon, United States

Forest Investigative Site 1699; 🇺🇸 San Antonio, Texas, United States

Forest Investigative Site 2011; 🇺🇸 Seattle, Washington, United States

Forest Investigative Site 1997; 🇺🇸 Madison, Wisconsin, United States