Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Roche

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: FP; Drug: Oral Corticosteroids; Drug: LABA; Drug: LAMA; Drug: Theophylline; Drug: LTRA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537691

MB29599

2015-000742-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 483 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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483 participants in 1 patient group

Inhaled Corticosteroids (ICS) + Controller Medications

Other group

Description:

Participants with severe asthma Global Initiative for Asthma (GINA) step 4/5 as indicated by current treatment with daily ICS consisting of \>/=500 mcg FP administered by DPI (or equivalent), and at least one of the following controller medications: LABAs, LTRAs, LAMAs, theophylline or oral corticosteroids.

Treatment:

Drug: LAMA

Drug: LTRA

Drug: FP

Drug: LABA

Drug: Theophylline

Drug: Oral Corticosteroids