Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-24 @ 5:19 PM
Study NCT ID:
NCT01875133
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2013-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients With Chronic Obstructive Pulmonary Disease At Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in exercise performance from baseline measured at 490 m', 'timeFrame': 'Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m', 'description': '6 min walk distance'}], 'secondaryOutcomes': [{'measure': 'Change in exercise performance from baseline measured at 490 m', 'timeFrame': 'Change in 6 min walk distance from 490 m baseline during 2 days at 1650 m', 'description': '6 min walk distance'}, {'measure': 'Change in pulmonary function from baseline measured at 490 m', 'timeFrame': 'Change in pulmonary function from 490 m baseline during 2 days at 2590 m', 'description': 'lung volumes by spirometry'}, {'measure': 'Change in pulmonary function from baseline measured at 490 m', 'timeFrame': 'Change in pulmonary function from 490 m baseline during 2 days at 1650 m', 'description': 'lung volumes by spirometry'}, {'measure': 'Change in arterial blood gases from baseline measured at 490 m', 'timeFrame': 'Change in arterial blood gases from 490 m baseline during 2 days at 2590 m', 'description': 'Arterial blood gas analysis'}, {'measure': 'Change in arterial blood gases from baseline measured at 490 m', 'timeFrame': 'Change in arterial blood gases from 490 m baseline during 2 days at 1650 m', 'description': 'Arterial blood gas analysis'}, {'measure': 'Change in perceived exertion from baseline measured at 490 m', 'timeFrame': 'Change in perceived exertion from 490 m baseline during 2 days at 2590 m', 'description': 'Borg CR10 scale at end of 6 min walk'}, {'measure': 'Change in perceived exertion from baseline measured at 490 m', 'timeFrame': 'Change in perceived exertion from 490 m baseline during 2 days at 1650 m', 'description': 'Borg CR10 scale at end of 6 min walk'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['airway disease', 'bronchitis', 'emphysema', 'lung'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '30936690', 'type': 'DERIVED', 'citation': 'Schwarz EI, Latshang TD, Furian M, Fluck D, Segitz S, Muller-Mottet S, Ulrich S, Bloch KE, Kohler M. Blood pressure response to exposure to moderate altitude in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Mar 14;14:659-666. doi: 10.2147/COPD.S194426. eCollection 2019.'}, {'pmid': '30464436', 'type': 'DERIVED', 'citation': 'Furian M, Flueck D, Latshang TD, Scheiwiller PM, Segitz SD, Mueller-Mottet S, Murer C, Steiner A, Ulrich S, Rothe T, Kohler M, Bloch KE. Exercise performance and symptoms in lowlanders with COPD ascending to moderate altitude: randomized trial. Int J Chron Obstruct Pulmon Dis. 2018 Oct 26;13:3529-3538. doi: 10.2147/COPD.S173039. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.', 'detailedDescription': 'Patients with moderate to severe COPD living below 800 m, will be recruited to participate in a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a 4 day sojourn at moderate altitude is reduced in comparison to low altitude. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m). The main outcome is the 6 minute walk distance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic obstructive pulmonary disease (COPD), GOLD grade 2-3\n* residents at low altitude (\\<800 m)\n\nExclusion Criteria:\n\n* Unstable condition, COPD exacerbation\n* Mild (GOLD 1) or very severe COPD (GOLD 4)\n* requirement for oxygen therapy at low altitude residence\n* hypoventilation\n* pulmonary hypertension\n* more than mild or unstable cardiovascular disease\n* use of drugs that affect respiratory center drive\n* internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\\>20 cigarettes per day), inability to perform 6 min walk test.\n* previous intolerance to moderate altitude (\\<2600m).\n* Exposure to altitudes \\>1500m for \\>2 days within the last 4 weeks before the study.\n* Pregnant or nursing patients'}, 'identificationModule': {'nctId': 'NCT01875133', 'briefTitle': 'Patients With Chronic Obstructive Pulmonary Disease At Altitude', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease', 'orgStudyIdInfo': {'id': '2013-0088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A: low-intermediate-high altitude', 'description': 'Altitude exposure sequence A, 490-1630-2590m', 'interventionNames': ['Other: altitude exposure']}, {'type': 'OTHER', 'label': 'B: low-high-intermediate altitude', 'description': 'Altitude exposure sequence B, 490-2590-1630 m', 'interventionNames': ['Other: altitude exposure']}, {'type': 'OTHER', 'label': 'C: intermediate-high-low altitude', 'description': 'Altitude exposure sequence C, 1630-2590-490 m', 'interventionNames': ['Other: altitude exposure']}, {'type': 'OTHER', 'label': 'D: high-intermediate-low altitude', 'description': 'Altitude exposure sequence D, 2590-1630-490 m', 'interventionNames': ['Other: altitude exposure']}], 'interventions': [{'name': 'altitude exposure', 'type': 'OTHER', 'description': 'stay at different altitudes: 490, 1630, 2590 m', 'armGroupLabels': ['A: low-intermediate-high altitude', 'B: low-high-intermediate altitude', 'C: intermediate-high-low altitude', 'D: high-intermediate-low altitude']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Pulmonary Division', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Konrad E Bloch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Zürich'}, {'name': 'Tsogyal D Latshang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}