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Sponsors and Collaborators: |
Air Liquide SA Inamed |
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Information provided by: | Air Liquide SA |
ClinicalTrials.gov Identifier: | NCT00801307 |
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.
Condition | Intervention | Phase |
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Asthma Chronic Obstructive Pulmonary Disease Healthy |
Device: spirometer |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Single Site,Exploratory,Phase I/II,Randomised Trial Comparing the Effect of He/O2 Mixtures(He/O2 78:22 and He/O2 65:35) to Medical Air on Pulmonary Function in Moderate/Severe Asthma and COPD Patients and Healthy Volunteers |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
He/O2 78:22
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Device: spirometer
According to the randomisation order, the appropriate medical gas cylinder with the pressure regulator will be connected to a humidifier to avoid the inhalation of very dry gas; the humidifier will be connected to the breathing bag; the flow of the medical gas will be adjusted individually for each subject/patient by the valve of the pressure regulator.
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2: Experimental
He/O2 65:35
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Device: spirometer
According to the randomisation order, the appropriate medical gas cylinder with the pressure regulator will be connected to a humidifier to avoid the inhalation of very dry gas; the humidifier will be connected to the breathing bag; the flow of the medical gas will be adjusted individually for each subject/patient by the valve of the pressure regulator.
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3: Active Comparator
Medical Air
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Device: spirometer
According to the randomisation order, the appropriate medical gas cylinder with the pressure regulator will be connected to a humidifier to avoid the inhalation of very dry gas; the humidifier will be connected to the breathing bag; the flow of the medical gas will be adjusted individually for each subject/patient by the valve of the pressure regulator.
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Two types of measurements will be performed with each of the three evaluated gases:
The working hypothesis is that when using He/O2 mixtures 78:22 and 65:35, the flow resistance decreases as compared to medical air because low density helium replaces nitrogen, thus resulting in a lower workload of breathing for asthmatic and COPD patients. For patients with reduced pulmonary function, this difference might result in greater Inspiratory Capacity.
That is why Inspiratory Capacity will be measured as primary efficacy criterion, but also Tidal Volume and other pulmonary function parameters on 3 types of subjects/patients :
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All subjects/patients:
Healthy volunteers:
Patients with moderate/severe persistent asthma:
Patients with moderate / severe COPD:
Exclusion Criteria:
Germany, Gauting | |
Inamed Research GmbH & Co. KG | Recruiting |
Robert-Koch-Allee 2, Gauting, Germany, 82131 | |
Contact: Thomas Meyer, Dr. med. Tel: + 49 89 893569 13 | |
Contact: Sabine Häussermann, PhD Tel: + 33 1 39 07 65 01 Sabine.HAUSSERMANN@airliquide.com | |
Principal Investigator: Thomas Meyer, Dr. med. |
Principal Investigator: | Thomas Meyer, Dr. med. | Inamed Research GmbH & Co. KG |
Responsible Party: | Air Liquide SA ( Mr Philippe ROUAULT/Director CRCD ) |
Study ID Numbers: | ALMED-07-C2-012, EudraCT number 2007-004158-10 |
Study First Received: | December 2, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00801307 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
evaluate Inspiratory Capacity (IC) measured by spirometry |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Healthy Respiratory Hypersensitivity Pulmonary Disease, Chronic Obstructive |
Immune System Diseases |