Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With COPD Traveling to High Altitude

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-12-31

Brief Summary

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The purpose of this randomized, placebo-controlled double-blind trial is to evaluate the effect of acetazolamide on right heart function at rest in lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude (HA) and developing early signs of altitude-illness.

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Detailed Description

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This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effect of acetazolamide on right heart function in lowlanders with chronic obstructive pulmonary disease (COPD) travelling to high altitude and developping early symptoms and/or signs of impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo treatment during their further stay of 2 days at 3'100 m.

Conditions

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Right Heart Function Chronic Obstructive Pulmonary Disease Altitude Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, placebo-controlled, double-blind

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) An independent pharmacist will prepare identically looking active and placebo capsules labelled with secret codes. Codes will be concealed to investigators and patients until completion of data analysis.

Study Groups

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Acetazolamide

Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.

Placebo

Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses

1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses

1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.

Interventions

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Acetazolamide

Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.

Intervention Type DRUG

Placebo

Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses

1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.

Intervention Type DRUG

Other Intervention Names

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Acetazolamide, oral capsule Placebo, oral capsule

Eligibility Criteria

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Inclusion Criteria

* Men and women, age 35-75 y, living at low altitude (\<800 m).
* COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, FEV1 40-80% predicted, pulse oximetry

≥92%, PaCO2 \<6 kPa, breathing ambient air at 760 m.
* One of the following early signs and/or symptoms of impending altitudeillness identified by self-monitoring during ascent to or stay at 3100 m:
* Pulse oximetry SpO2≤84%
* Headache or nausea/vomiting or fatigue/weakness or dizziness/lightheadedness of at least moderate intensity

Exclusion Criteria

* COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see above).
* Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular disease, i.e., unstable arterial hypertension, coronary artery disease; previous stroke; obesity (body mass index \>35 kg/m2); internal, neurologic, rheumatologic or psychiatric disease; current heavy smoking (\>20 cigarettes per day).
* Renal failure and/or allergy to sulfonamides.
* Patients who do not have early signs and/or signs of impending altitudeillness by self-monitoring (as defined above) at 3'100m will not be included.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No