Status:
COMPLETED
Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease
Lead Sponsor:
Air Liquide SA
Collaborating Sponsors:
Inamed
Conditions:
Asthma
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial will include healthy volunteers, COPD patients and asthmatic patients who will breathe He/O2 78:22, He/O2 65:35 and medical air consecutively in a randomised order.
Detailed Description
Two types of measurements will be performed with each of the three evaluated gases: * pulmonary function measurements at rest to establish the resistance to airflow in a reproducible way, including t...
Eligibility Criteria
Inclusion
- All subjects/patients:
- Willing and able to complete the requirements of this study including the signature of the written informed consent,
- Able to complete the study in 5 working days or less,
- Able to perform pulmonary function tests
- Healthy volunteers:
- Never smoker or subject who stopped smoking at least 6 months before selection (strictly less than 10 pack-years),
- Having pulmonary function tests within the normal range(according to predicted values for age, sex and height as referenced in ATS/ERS 1993 standards)
- Patients with moderate/severe persistent asthma:
- Documented clinical diagnosis of moderate or severe persistent asthma (according to GINA 2006 guidelines),
- Stable asthma in the 4 weeks prior to selection as evidenced by no change in asthma medication, no treatment for asthma in an emergency,acute care setting and no admission to hospital for acute asthma
- Patients with moderate / severe COPD:
- Aged ≥ 45 and £ 80 years old,
- Documented clinical diagnosis of moderate or severe COPD(according to GOLD 2006 guidelines),
- With a smoking history of 10 pack-years or more,
- Stable COPD in the 4 weeks prior to selection as evidenced by no change in COPD medication, no treatment for COPD in an emergency, acute care setting and no admission to hospital for COPD exacerbation
Exclusion
- Obese subject/patient having a Body Mass Index (BMI) \> 35,
- Past or present respiratory disease including being free from the common cold and rhinitis for at least 4 weeks before selection except asthma for asthmatic patients and COPD for COPD patients,
- Daily need for 12 hours or more of long term oxygen therapy,
- Pregnant or lactating woman,
- Lack of efficient contraception according to CPMP/ICH 286/95 note 31,
- Any contra-indication to perform pulmonary function tests or light cycling exercise,
- Clinically significant or uncontrolled pathologic conditions which may interfere with the study procedures,
- Drug abuse or psychic disorders resulting in an inability to fully understand the requirements of the study,
- Legal status which prohibits informed consent,
- Participation in any interventional clinical trial within 30 days prior to selection
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00801307
Start Date
June 1 2008
End Date
March 1 2010
Last Update
August 11 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Inamed Research GmbH & Co. KG
Robert-Koch-Allee 2, Gauting, Germany, 82131