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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03177850 |
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Date of registration:
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23/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory Disease at Altitude
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Scientific title:
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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 |
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Date of first enrolment:
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May 24, 2017 |
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Target sample size:
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185 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03177850 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Kyrgyzstan
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Contacts
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Name:
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Talant M Sooronbaev, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan |
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Name:
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Konrad E Bloch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zurich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female patients, age 18-75 yrs.
- COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 =92% at 750 m.
- Born, raised and currently living at low altitude (<800m).
- Written informed consent.
Exclusion Criteria:
- 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).
- Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic
arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in
the last 2 months.
- Internal, neurologic, rheumatologic or psychiatric disease including current heavy
smoking (>20 cigarettes per day)
- Known renal failure or allergy to acetazolamide and other sulfonamides
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Drug: Placebo oral capsule
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Drug: ACETAZOLAMIDE oral capsule
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Primary Outcome(s)
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Change in nocturnal oxygen saturation
[Time Frame: night 1 at 760m and night 1 at 3200 m]
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Change in nocturnal oxygen desaturation index
[Time Frame: night 1 at 760m and night 1 at 3200 m]
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Secondary Outcome(s)
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Change in apnea/hypopnea index
[Time Frame: night 1 at 760m and night 2 at 3200 m]
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Change in nocturnal oxygen saturation
[Time Frame: night 1 at 760m and night 2 at 3200 m]
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Change in apnea/hypopnea index
[Time Frame: night 1 at 760m and night 1 at 3200 m]
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Change in subjective sleepiness and sleep quality
[Time Frame: Day 1 and 2 at 760m and 3200m]
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Change in nocturnal oxygen desaturation index
[Time Frame: night 1 at 760m and night 2 at 3200 m]
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Secondary ID(s)
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2017-00137D
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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