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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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Formoterol Fumarate in the Pressair DPI, low dose (Drug); Formoterol Fumarate in the Pressair DPI 6 mcg, twice a day for 14 days (Drug); Foradil Aerolizer, low dose (Drug); Foradil Aerolizer, high dose (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Carrie D'Andrea, MS, Study Director, Affiliation: Forest Laboratories

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.

Clinical Details

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

Primary outcome: Change from baseline in normalized Forced Expiratory Volume in One Second (FEV1) area under the curve

Secondary outcome:

Change from baseline in normalized FEV1 area under the curve

Adverse event (AE) recording

Vital Signs

Electrocardiograms (ECGs)

Clinical Laboratory Measures

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Forest Investigative Site 909, Phoenix, Arizona 85006, United States

Forest Investigative Site 2066, Encinitas, California 92024, United States

Forest Investigative Site 1624, Los Angeles, California 90025, United States

Forest Investigative Site 1995, Mission Viejo, California 92691, United States

Forest Investigative Site 1347, San Jose, California 95117, United States

Forest Investigative Site 1996, Centennial, Colorado 80112, United States

Forest Investigative Site 1137, Colorado Springs, Colorado 80907, United States

Forest Investigative Site 1998, Denver, Colorado 80230, United States

Forest Investigative Site 2047, Tampa, Florida 33613, United States

Forest Investigative Site 1536, Louisville, Kentucky 40215, United States

Forest Investigative Site 1333, Baltimore, Maryland 21236, United States

Forest Investigative Site 1431, North Dartmouth, Massachusetts 02747, United States

Forest Investigative Site 2041, Minneapolis, Minnesota 55402, United States

Forest Investigative Site 1599, Saint Louis, Missouri 63141, United States

Forest Investigative Site 1609, Bellevue, Nebraska 68123, United States

Forest Investigative Site 1999, Skillman, New Jersey 08558, United States

Forest Investigative Site 1153, Raleigh, North Carolina 27607, United States

Forest Investigative Site 1134, Canton, Ohio 44718, United States

Forest Investigative Site 1806, Cincinnati, Ohio 45231, United States

Forest Investigative Site 1176, Oklahoma City, Oklahoma 73120, United States

Forest Investigative Site 2043, Medford, Oregon 97504, United States

Forest Investigative Site 1580, Portland, Oregon 97202, United States

Forest Investigative Site 2025, Charleston, South Carolina 29407, United States

Forest Investigative Site 1155, Dallas, Texas 75231, United States

Forest Investigative Site 1332, El Paso, Texas 79903, United States

Forest Investigative Site 1370, New Braunfels, Texas 78130, United States

Forest Investigative Site 1699, San Antonio, Texas 78229, United States

Forest Investigative Site 2011, Seattle, Washington 98115, United States

Forest Investigative Site 1997, Madison, Wisconsin 53792, United States

Additional Information

Starting date: June 2012
Last updated: February 13, 2013

Page last updated: August 23, 2015

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