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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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15 November 2021 |
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Main ID: |
NCT03540901 |
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Date of registration:
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15/05/2018 |
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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 Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude
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Scientific title:
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Effect of Acetazolamide on Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial |
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Date of first enrolment:
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May 22, 2018 |
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Target sample size:
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112 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03540901 |
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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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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 Hospital, Zürich |
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Name:
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Michael Furian, MSc |
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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 Hospital, Zürich |
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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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Silvia Ulrich, 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 Hospital, Zürich |
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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, Oxygen Saturation (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/Forced Vital
Capacity <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; obstructive sleep
apnea; 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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Difference in change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group
[Time Frame: Day 2 at 760m and 3100m]
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Secondary Outcome(s)
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Change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide and in the placebo group, respectively
[Time Frame: Day 2 at 3100m]
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Secondary ID(s)
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2017-00137G
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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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