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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641081
• Other study ID #: LAC-MD-21
• Status: Completed
• Phase: Phase 2
• First received: July 12, 2012
• Last updated: September 15, 2016
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Formoterol Fumarate in the Pressair DPI, low dose
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
• Formoterol Fumarate in the Pressair DPI 6 mcg, twice a day for 14 days
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
• Foradil Aerolizer, low dose
Foradil Aerolizer 12 micrograms, twice a day for 14 days
• Foradil Aerolizer, high dose
Foradil Aerolizer 24 micrograms, twice per day for 14 days
• Placebo
Placebo in the Pressair for 14 days

Locations

Country	Name	City	State
United States	Forest Investigative Site 1333	Baltimore	Maryland
United States	Forest Investigative Site 1609	Bellevue	Nebraska
United States	Forest Investigative Site 1134	Canton	Ohio
United States	Forest Investigative Site 1996	Centennial	Colorado
United States	Forest Investigative Site 2025	Charleston	South Carolina
United States	Forest Investigative Site 1806	Cincinnati	Ohio
United States	Forest Investigative Site 1137	Colorado Springs	Colorado
United States	Forest Investigative Site 1155	Dallas	Texas
United States	Forest Investigative Site 1998	Denver	Colorado
United States	Forest Investigative Site 1332	El Paso	Texas
United States	Forest Investigative Site 2066	Encinitas	California
United States	Forest Investigative Site 1624	Los Angeles	California
United States	Forest Investigative Site 1536	Louisville	Kentucky
United States	Forest Investigative Site 1997	Madison	Wisconsin
United States	Forest Investigative Site 2043	Medford	Oregon
United States	Forest Investigative Site 2041	Minneapolis	Minnesota
United States	Forest Investigative Site 1995	Mission Viejo	California
United States	Forest Investigative Site 1370	New Braunfels	Texas
United States	Forest Investigative Site 1431	North Dartmouth	Massachusetts
United States	Forest Investigative Site 1176	Oklahoma City	Oklahoma
United States	Forest Investigative Site 909	Phoenix	Arizona
United States	Forest Investigative Site 1580	Portland	Oregon
United States	Forest Investigative Site 1153	Raleigh	North Carolina
United States	Forest Investigative Site 1599	Saint Louis	Missouri
United States	Forest Investigative Site 1699	San Antonio	Texas
United States	Forest Investigative Site 1347	San Jose	California
United States	Forest Investigative Site 2011	Seattle	Washington
United States	Forest Investigative Site 1999	Skillman	New Jersey
United States	Forest Investigative Site 2047	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in normalized Forced Expiratory Volume in One Second (FEV1) area under the curve	Change from baseline in normalized FEV1 Area Under the Curve (AUC) from time 0 to 6 hours (AUC 0h-6h) after the morning dose of investigational product at Day 14 across treatment periods.	Day 14	No
Secondary	Change from baseline in normalized FEV1 area under the curve	The secondary efficacy parameters are change from baseline in normalized FEV1 area under the curve from time 0 to 6 hours (AUC 0h-6h) after the morning dose of investigational product at Day 1 across treatment periods and change from baseline in FEV1 at each specific time point at Days 1 and 14 across treatment periods.	Day 1 and Day 14	No
Secondary	Adverse event (AE) recording	Number of patients to experience a Treatment Emergent Adverse Event (TEAE)	14 Days	Yes
Secondary	Vital Signs	Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight	14 Days	Yes
Secondary	Electrocardiograms (ECGs)	Number of patients to experience potentially clinically significant changes in ECG from Baseline.	14 Days	Yes
Secondary	Clinical Laboratory Measures	Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry or Urinalysis.	14 Days	Yes

External Links

•   CSR Synopsis