Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

• Status: Completed
• Trial end date: 2017-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Theophylline

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