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Due to low recruitment rate the sponsor decided to discontinue the study.
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| Name | Class |
|---|---|
| Asklepios Kliniken Hamburg GmbH | OTHER |
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The purpose of this study is to evaluate effects of inspired gas mixtures on the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test.
the purpose of this study is to evaluate the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test (6MWT) while breathing Helium/Oxygen 65%/35% compared to either breathing Nitrogen/Oxygen 65%/35% or receiving Non-Invasive Ventilation (NIV) with a FiO2 of 0.35 and to evaluate exercise related symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhalation Nitrogen/Oxygen | Active Comparator | Nitrogen/Oxygen (65%/35%) |
|
| Inhalation Helium/Oxygen | Experimental | Helium/Oxygen (65%/35%) |
|
| Inhalation gas | Experimental | Medicinal oxygen 100% via NIV with FiO2 of 0.35 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalation gas | Drug | Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance walked | evaluate the distance walked by patients during a Six-Minute Walk Test | 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety of inhalation Helium/Oxygen | evaluate the safety of the administration of Helium/Oxygen 65%/35% | 6 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl HAUSSINGER, Prof Dr Med | Asklepios fachkliniken München-Gauting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios Fachkliniken München-Gauting | Gauting | Gauting | 82131 | Germany |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Inhalation Nitrogen/Oxygen | Drug | Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes |
|
|
| Inhalation Helium/Oxygen | Drug | Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes |
|
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |