Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | August 28, 2015 |
End Date: | July 10, 2017 |
A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma
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.
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.
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
We found this trial at
30
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of South Florida The University of South Florida is a high-impact, global research university...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
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Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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