Status:
COMPLETED
The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome
Lead Sponsor:
Laval University
Conditions:
Asthma
COPD
Eligibility:
All Genders
45+ years
Brief Summary
RATIONALE: In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated...
Eligibility Criteria
Inclusion
- ALL SUBJECTS
- Subjects aged 45 years and older.
- Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
- Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
- Free of respiratory infection in the 4 weeks preceding the study.
- No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
- If female, not pregnant (or lactating).
- Able to adhere to study procedures.
- Able and willing to provide written informed consent to participate in the study, in accordance with international conference on harmonization (ICH) good clinical practice (GCP) requirements.
- ACOS SUBJECTS
- 1\. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS
- Long-life non-smokers or ex-smokers defined as someone who smoked less than 5 pack-years and who completely stopped smoking for at least 12 months before inclusion in the study.
- With an IRAO.
Exclusion
- ALL SUBJECTS
- With COPD without a past diagnosis of asthma.
- Unstable respiratory or non-respiratory condition.
- Any active chronic inflammatory disease.
- Any evidence of malignancy (active and/or treated) within the previous 5 years.
- Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
- Any history of bronchial thermoplasty. IRAO SUBJECTS
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- Use of any nicotine containing product within 1 year prior to study entry or a smoking history of \> 5 pack-years.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03817333
Start Date
March 1 2014
End Date
December 1 2017
Last Update
January 25 2019
Active Locations (1)
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1
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5