Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Completed · Phase 4

Conditions studied: Asthma

In brief

Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

Key facts

Study ID

NCT02537691

Run by

Hoffmann-La Roche

People needed

483

Starts

2015-08-28

Expected to finish

2017-07-10

Last updated by the study team

2019-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Asthma diagnosed by a respiratory physician greater than or equal to (>/=) 12 months prior to study enrolment
• Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1
• Documented bronchodilator response defined as >/=12% relative improvement in FEV1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (<) 8 milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline
• Current treatment with a total daily dose of >/= 500 micrograms (mcg) of fluticasone propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the following controller medications: long-acting Beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/Visit 1

You may not qualify if…

• Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks prior to participant eligibility
• Acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to study
• Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline/Visit 1
• Ex-smokers with >/=10 pack-year smoking history
• Prior treatment with bronchial thermoplasty
• Participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/Visit 1 or during the study
• Pregnancy prior to participation or during the study

Where it is running

• Southern California Research Center — Mission Viejo, California, United States
• Capital Allergy Resp Dis Ctr — Sacramento, California, United States
• Allergy Assoc Medical Group — San Diego, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Waterbury Pulmonary Associates — Waterbury, Connecticut, United States
• AAADRS; Clinical Research Center — Coral Gables, Florida, United States
• Volunteer Medical Research — Port Charlotte, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Georgia Pollens Clinical Research Centers — Albany, Georgia, United States
• Asthma & Allergy Center, P.C. — Papillion, Nebraska, United States
• Allergy & Asthma Research of Nj, Inc — Mount Laurel, New Jersey, United States
• Island Medical Research Pc — Commack, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Laura and ISAAC Perlmutter Cancer Center at NYU Langone. — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Vital Prospects Clin Res Pc — Tulsa, Oklahoma, United States
• Allergy-Asthma Specialists PC — Blue Bell, Pennsylvania, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Allergy & Clinical Immun Assoc — Pittsburgh, Pennsylvania, United States
• Berks-Schuylkill Respiratory Specialists, Ltd — Wyomissing, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Allergy & Asthma Res Ctr PA — San Antonio, Texas, United States
• Allergy Associates of Utah — Murray, Utah, United States
• Bridgerland Clinical Research — North Logan, Utah, United States
• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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