Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD

NCT ID: NCT04913389

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this randomized, placebo-controlled double-blind trial is to evaluate efficacy of acetazolamide in preventing overt altitude-related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease (COPD) developing early signs of altitude-illness during altitude travel.

Detailed Description

This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effectiveness of acetazolamide in reducing the incidence of predefined altitude-related adverse health effects 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.

An interim-analysis will be performed after the first year of the study or when 38 participants are randomized, whichever comes first. Symmetric stopping boundaries at P<0.001 will be applied (Peto approach).

Conditions

Chronic Obstructive Pulmonary Disease; Altitude Sickness; Altitude Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Acetazolamide

Acetazolamide (oral capsules)

Group Type: ACTIVE_COMPARATOR

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)

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

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

Acetazolamide, oral capsule; Placebo, oral capsule

Eligibility Criteria

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, forced expiratory volume in one second 40-80% predicted, pulse oximetry ≥92%, PaCO2 <6 kilopascal, breathing ambient air at 760 m.
• One of the following early signs and/or symptoms of impending altitude-illness 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/light-headedness 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 altitude-illness 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

Sponsors

National Center of Cardiology and Internal Medicine, Kyrgyz Republic

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad E Bloch

Role: STUDY_CHAIR

University Hospital, Zürich, Switzerland

Talant M Sooronbaev

Role: STUDY_DIRECTOR

National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Michael Furian

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Locations

National Center of Cardiology and Internal Medicine

Bishkek, , Kyrgyzstan

Countries

Kyrgyzstan

Other Identifiers

01-2021-KEB

Identifier Type: -

Identifier Source: org_study_id