Overview

This trial is active, not recruiting.

Condition asthma
Treatments fp, laba, ltra, lama, theophylline, oral corticosteroids
Phase phase 4
Sponsor Hoffmann-La Roche
Start date August 2015
End date July 2017
Trial size 483 participants
Trial identifier NCT02537691, 2015-000742-35, MB29599

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose health services research
Masking no masking
Arm
(Other)
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.
fp
ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.
laba
LABA will be administered as per investigator discretion.
ltra
LTRA will be administered as per investigator discretion.
lama
LAMA will be administered as per investigator discretion.
theophylline
Theophylline will be administered as per investigator discretion.
oral corticosteroids
Oral corticosteroids will be administered as per investigator discretion.

Primary Outcomes

Measure
Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin
time frame: Baseline up to Week 52

Secondary Outcomes

Measure
Percentage of Participants With Asthma Exacerbations
time frame: Baseline up to Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points
time frame: Baseline, Weeks 26, 52
Time Taken for the Occurrence of First Asthma Exacerbation
time frame: Baseline up to Week 52
Time to Treatment Failure
time frame: Baseline up to Week 52
Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points
time frame: Baseline, Weeks 13, 26, 39, 52
Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points
time frame: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)
Change From Baseline in Asthma Control Test (ACT) at Specified Time Points
time frame: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)
Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee
time frame: Baseline up to Week 52
Serum Periostin Levels During the Study
time frame: Baseline, Weeks 26, 52
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
time frame: Baseline, Weeks 26, 52
Blood Eosinophil Levels During the Study
time frame: Baseline, Weeks 26, 52
Serum Immunoglobulin E (IgE) Levels During the Study
time frame: Baseline, Weeks 26, 52
Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations
time frame: Weeks 13, 26, 39, 52
Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits
time frame: Weeks 13, 26, 39, 52
Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits
time frame: Weeks 13, 26, 39, 52

Eligibility Criteria

All participants at least 18 years old.

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 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

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 February 2017.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.