Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-11 @ 1:19 PM
Study NCT ID:
NCT03177850
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2017-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory 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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-26', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in nocturnal oxygen saturation', 'timeFrame': 'night 1 at 760m and night 1 at 3200 m', 'description': 'Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group'}, {'measure': 'Change in nocturnal oxygen desaturation index', 'timeFrame': 'night 1 at 760m and night 1 at 3200 m', 'description': 'Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group'}], 'secondaryOutcomes': [{'measure': 'Change in nocturnal oxygen saturation', 'timeFrame': 'night 1 at 760m and night 2 at 3200 m', 'description': 'Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group'}, {'measure': 'Change in nocturnal oxygen desaturation index', 'timeFrame': 'night 1 at 760m and night 2 at 3200 m', 'description': 'Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group'}, {'measure': 'Change in apnea/hypopnea index', 'timeFrame': 'night 1 at 760m and night 1 at 3200 m', 'description': 'Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group'}, {'measure': 'Change in apnea/hypopnea index', 'timeFrame': 'night 1 at 760m and night 2 at 3200 m', 'description': 'Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group'}, {'measure': 'Change in subjective sleepiness and sleep quality', 'timeFrame': 'Day 1 and 2 at 760m and 3200m', 'description': 'Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep related breathing disturbances', 'respiratory polygraphy', 'airway disease', 'emphysema', 'acetazolamide', 'altitude', 'nocturnal pulse oxymetry'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.', 'detailedDescription': "This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.\n\nSleep related breathing disturbances will be evaluated by respiratory polygraphy.\n\nAn interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients, age 18-75 yrs.\n* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.\n* Born, raised and currently living at low altitude (\\<800m).\n* Written informed consent.\n\nExclusion Criteria:\n\n* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \\<0.7, FEV1 \\<40% predicted, oxygen saturation on room air \\<92% at 750 m).\n* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.\n* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\\>20 cigarettes per day)\n* Known renal failure or allergy to acetazolamide and other sulfonamides'}, 'identificationModule': {'nctId': 'NCT03177850', 'briefTitle': 'Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory Disease at Altitude', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease at Altitude, Assessed by Respiratory Polygraphy: A Randomized, Placebo-controlled, Double-blind Parallel Trial', 'orgStudyIdInfo': {'id': '2017-00137D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACETAZOLAMIDE oral capsule', 'description': 'Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m', 'interventionNames': ['Drug: ACETAZOLAMIDE oral capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO oral capsule', 'description': 'Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m.', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'ACETAZOLAMIDE oral capsule', 'type': 'DRUG', 'description': 'Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m', 'armGroupLabels': ['ACETAZOLAMIDE oral capsule']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m', 'armGroupLabels': ['PLACEBO oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '720040', 'city': 'Bishkek', 'country': 'Kyrgyzstan', 'facility': 'National Center of Cardiology and Internal Medicine', 'geoPoint': {'lat': 42.87, 'lon': 74.59}}], 'overallOfficials': [{'name': 'Konrad E Bloch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Zurich'}, {'name': 'Talant M Sooronbaev, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}