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Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

NCT02537691

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Asthma

Interventions: FP, LABA, LTRA, LAMA, Theophylline

Countries: United States, Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (100)
  • Birmingham, Alabama, United States
  • Mission Viejo, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • New Haven, Connecticut, United States
  • Waterbury, Connecticut, United States
  • Coral Gables, Florida, United States
  • Port Charlotte, Florida, United States
  • Tampa, Florida, United States
  • Albany, Georgia, United States
  • Papillion, Nebraska, United States
  • Mount Laurel, New Jersey, United States
  • Commack, New York, United States
  • Mineola, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Tulsa, Oklahoma, United States
  • Blue Bell, Pennsylvania, United States
  • Hershey, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Wyomissing, Pennsylvania, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Murray, Utah, United States
  • North Logan, Utah, United States
  • Charlottesville, Virginia, United States
  • Fairfax, Virginia, United States
  • Seattle, Washington, United States
  • Spokane, Washington, United States
  • Brussels, Belgium
  • + 70 more on CT.gov