Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

• ClinicalTrials.gov Identifier: NCT02537691
• Recruitment Status: Completed
• First Posted: September 2, 2015
• Last Update Posted: April 9, 2019
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: August 27, 2015
• First Posted Date: September 2, 2015
• Last Update Posted Date: April 9, 2019
• Actual Study Start Date: August 28, 2015
• Actual Primary Completion Date: July 10, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 15, 2017): 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 ]
• Original Primary Outcome Measures (submitted: September 1, 2015): Rate of Asthma Exacerbations in Participants with High Baseline Periostin Compared to participants with Low Baseline Periostin [ Time Frame: Baseline through Week 52 ]

Current Secondary Outcome Measures (submitted: February 15, 2017)

• 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 ]

Original Secondary Outcome Measures (submitted: September 1, 2015)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
• Official Title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Asthma

Intervention

• Drug: FP
  ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.
• Drug: LABA
  LABA will be administered as per investigator discretion.
• Drug: LTRA
  LTRA will be administered as per investigator discretion.
• Drug: LAMA
  LAMA will be administered as per investigator discretion.
• Drug: Theophylline
  Theophylline will be administered as per investigator discretion.
• Drug: Oral Corticosteroids
  Oral corticosteroids will be administered as per investigator discretion.

Study Arms

Inhaled Corticosteroids (ICS) + Controller Medications

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.

Interventions:

• Drug: FP
• Drug: LABA
• Drug: LTRA
• Drug: LAMA
• Drug: Theophylline
• Drug: Oral Corticosteroids

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 1, 2016): 483
• Original Estimated Enrollment (submitted: September 1, 2015): 1213
• Actual Study Completion Date: July 10, 2017
• Actual Primary Completion Date: July 10, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Latvia, Netherlands, Portugal, Russian Federation, Spain, United Kingdom, United States
• Removed Location Countries: India, Turkey

Administrative Information

• NCT Number: NCT02537691
• Other Study ID Numbers: MB29599; 2015-000742-35 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Hoffmann-La Roche
• Study Sponsor: Hoffmann-La Roche
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: April 2019