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OpenTrials
Completed

NCT Number: NCT02537691

Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Erasme; Neurologie, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FP

Drug

ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.

LABA

Drug

LABA will be administered as per investigator discretion.

LTRA

Drug

LTRA will be administered as per investigator discretion.

LAMA

Drug

LAMA will be administered as per investigator discretion.

Theophylline

Drug

Theophylline will be administered as per investigator discretion.

Oral corticosteroids

Drug

Oral corticosteroids will be administered as per investigator discretion.

Primary outcomes

  1. 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

  1. Percentage of Participants With Asthma Exacerbations

    Time frame: Baseline up to Week 52

  2. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points

    Time frame: Baseline, Weeks 26, 52

  3. Time Taken for the Occurrence of First Asthma Exacerbation

    Time frame: Baseline up to Week 52

  4. Time to Treatment Failure

    Time frame: Baseline up to Week 52

  5. Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points

    Time frame: Baseline, Weeks 13, 26, 39, 52

  6. 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)

  7. 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)

  8. 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

  9. Serum Periostin Levels During the Study

    Time frame: Baseline, Weeks 26, 52

  10. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels

    Time frame: Baseline, Weeks 26, 52

  11. Blood Eosinophil Levels During the Study

    Time frame: Baseline, Weeks 26, 52

  12. Serum Immunoglobulin E (IgE) Levels During the Study

    Time frame: Baseline, Weeks 26, 52

  13. Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations

    Time frame: Weeks 13, 26, 39, 52

  14. Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits

    Time frame: Weeks 13, 26, 39, 52

  15. Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits

    Time frame: Weeks 13, 26, 39, 52

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2015
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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