Asthma Exacerbation Study

Completed · Phase 3

Conditions studied: Asthma

In brief

This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.

Key facts

Study ID

NCT01086384

Run by

GlaxoSmithKline

People needed

2020

Starts

2010-02-22

Expected to finish

2011-09-15

Last updated by the study team

2018-01-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of asthma
• Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
• FEV1 of fifty to ninety percent of predicted
• Currently using inhaled corticosteroid therapy
• History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year

You may not qualify if…

• History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
• Respiratory infection or oral candidiasis
• - Uncontrolled disease or clinical abnormality
• Allergies
• Taking another investigational medication or prohibited medication

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Oxford, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Bell Gardens, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Napa, California, United States
• GSK Investigational Site — Rancho Mirage, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Stockton, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Englewood, Colorado, United States
• GSK Investigational Site — Cocoa, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Valrico, Florida, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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