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Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537691
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE August 28, 2015
Actual Primary Completion Date July 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2016)
483
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
1213
Actual Study Completion Date  ICMJE July 10, 2017
Actual Primary Completion Date July 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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  ICMJE NCT02537691
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP