Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02537691
• Date of registration: 27/08/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
• Scientific title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma
• Date of first enrolment: August 28, 2015
• Target sample size: 483
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02537691
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, India, Italy, Latvia, Netherlands, Portugal, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: LABA

Drug: LAMA

Drug: LTRA

Drug: Theophylline

Drug: Oral Corticosteroids

Drug: FP

Primary Outcome(s)

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 Outcome(s)

Blood Eosinophil 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]

Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points [Time Frame: Baseline, Weeks 26, 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)]

Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations [Time Frame: Weeks 13, 26, 39, 52]

Time Taken for the Occurrence of First Asthma Exacerbation [Time Frame: Baseline up to Week 52]

Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits [Time Frame: Weeks 13, 26, 39, 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]

Serum Periostin Levels During the Study [Time Frame: Baseline, Weeks 26, 52]

Time to Treatment Failure [Time Frame: Baseline up to Week 52]

Percentage of Participants With Asthma Exacerbations [Time Frame: Baseline 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]

Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits [Time Frame: Weeks 13, 26, 39, 52]

Serum Immunoglobulin E (IgE) Levels During the Study [Time Frame: Baseline, Weeks 26, 52]

Secondary ID(s)

2015-000742-35

MB29599

Source(s) of Monetary Support

Please refer to primary and secondary sponsors