Overview

This trial is active, not recruiting.

Condition asthma
Treatment laboratory biomarker analysis
Phase phase 4
Sponsor Hoffmann-La Roche
Start date August 2015
End date June 2017
Trial size 483 participants
Trial identifier NCT02537691, 2015-000742-35, MB29599

Summary

Prospective, single-arm, longitudinal, international, multicentre 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Other)
Participants with severe asthma Global Initiative for Asthma (GINA) step 4/5 as indicated by current treatment with daily inhaled corticosteroids (ICS) consisting of >/= 500 micrograms fluticasone propionate (FP) administered by dry powder inhaler (DPI) (or equivalent), and at least one of the following controller medications: long-acting beta-agonists (LABAs), leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids.
laboratory biomarker analysis

Primary Outcomes

Measure
Rate of Asthma Exacerbations in Participants with High Baseline Periostin Compared to participants with Low Baseline Periostin
time frame: Baseline through Week 52

Secondary Outcomes

Measure
Percentage of Participants with Asthma Exacerbations
time frame: Baseline through Week 52
Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
time frame: Baseline through Week 52
Time Taken for the Occurrence of First Asthma Exacerbation
time frame: Baseline through Week 52
Time to Treatment Failure
time frame: Baseline through Week 52
Asthma-Specific Health-Related Quality of Life as Assessed by the Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ)
time frame: Baseline through Week 52
Change in Asthma-Specific Symptom Scores, as Assessed by the Asthma Control Questionnaire-7 (ACQ-7) and the Asthma Control Test (ACT)
time frame: Baseline through Week 52
Association Between Baseline Periostin and Clinically Meaningful Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee
time frame: Baseline through Week 52
Association Between Periostin and Other Biomarker Levels Measured at Baseline and Rate of Urgent Asthma-Related Health Care Utilization Over Study Period
time frame: Baseline through Week 52
Serum Periostin Levels During the Study
time frame: Baseline through Week 52
Fractional Exhaled Nitric Oxide (FeNO) Levels During the Study
time frame: Baseline through Week 52
Blood Eosinophil Levels During the Study
time frame: Baseline through Week 52
Serum Immunoglobulin E (Ig E) Levels During the Study
time frame: Baseline through Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Males and females >/= 18 years of age - Asthma diagnosed by a respiratory physician >/= 12 months prior to study enrolment - Pre-bronchodilator forced expiratory volume in 1 second (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 PC20 (provocative concentration causing a 20% fall in FEV1) < 8 mg at study baseline/Visit 1 or within 24 months prior to baseline. - Current treatment with a total daily dose of >/= 500 micrograms of FP DPI (or equivalent ) and at least one of the following controller medications: LABA, LTRA, LAMA, 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 - Acute asthma exacerbation 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 study - 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 study or during the study - Pregnancy prior to participation or during the study

Additional Information

Official title A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.