Clinical trial NCT01641081: Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
timeFrame: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
Secondary outcomes:
measure: Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
timeFrame: Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Forest Investigative Site 909
state: Arizona
city: Encinitas
country: United States
facility: Forest Investigative Site 2066
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 1624
state: California
city: Mission Viejo
country: United States
facility: Forest Investigative Site 1995
state: California
city: San Jose
country: United States
facility: Forest Investigative Site 1347
state: California
city: Centennial
country: United States
facility: Forest Investigative Site 1996
state: Colorado
city: Colorado Springs
country: United States
facility: Forest Investigative Site 1137
state: Colorado
city: Denver
country: United States
facility: Forest Investigative Site 1998
state: Colorado
city: Tampa
country: United States
facility: Forest Investigative Site 2047
state: Florida
city: Louisville
country: United States
facility: Forest Investigative Site 1536
state: Kentucky
city: Baltimore
country: United States
facility: Forest Investigative Site 1333
state: Maryland
city: North Dartmouth
country: United States
facility: Forest Investigative Site 1431
state: Massachusetts
city: Minneapolis
country: United States
facility: Forest Investigative Site 2041
state: Minnesota
city: Saint Louis
country: United States
facility: Forest Investigative Site 1599
state: Missouri
city: Bellevue
country: United States
facility: Forest Investigative Site 1609
state: Nebraska
city: Skillman
country: United States
facility: Forest Investigative Site 1999
state: New Jersey
city: Raleigh
country: United States
facility: Forest Investigative Site 1153
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site 1134
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 1806
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 1176
state: Oklahoma
city: Medford
country: United States
facility: Forest Investigative Site 2043
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 1580
state: Oregon
city: Charleston
country: United States
facility: Forest Investigative Site 2025
state: South Carolina
city: Dallas
country: United States
facility: Forest Investigative Site 1155
state: Texas
city: El Paso
country: United States
facility: Forest Investigative Site 1332
state: Texas
city: New Braunfels
country: United States
facility: Forest Investigative Site 1370
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 1699
state: Texas
city: Seattle
country: United States
facility: Forest Investigative Site 2011
state: Washington
city: Madison
country: United States
facility: Forest Investigative Site 1997
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References: