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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004158-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Inamed | INDUSTRY |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | He/O2 78:22 |
|
| 2 | Experimental | He/O2 65:35 |
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| 3 | Active Comparator | Medical Air |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spirometer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Capacity measured by spirometry at rest while breathing each He/O2 mixture compared to its measurement on medical air | 30 mn |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Capacity measured by ergospirometry while breathing Pulmonary function parameters at rest, i.e., FEV1, FVC, FEF25-75, PEF and ERV while breathing each He/O2 mixture compared to medical air, | 20 Mn |
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Inclusion Criteria:
All subjects/patients:
Healthy volunteers:
Patients with moderate/severe persistent asthma:
Patients with moderate / severe COPD:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Meyer, Dr. med. | Inamed Research GmbH & Co. KG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inamed Research GmbH & Co. KG | Robert-Koch-Allee 2 | Gauting | 82131 | Germany |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |