Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Novel Approach to Prevention of Altitude-related Illness in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04913389
• Other study ID #: 01-2021-KEB
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Hypoxia
• Altitude Sickness
• Chronic Obstructive Pulmonary Disease
• Hypoxia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Kyrgyzstan	National Center of Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyz Republic

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of altitude-related adverse health effects	Difference between participants receiving acetazolamide and placebo in the incidence of altitude-related adverse health effects defined as: Moderate to severe acute mountain sickness (Lake Louise score >4 including headache and/or Acute Mountain Sickness cerebral score =0.7); Severe hypoxemia (SpO2 at rest <80% for >30 min; or SpO2 <75% for >15 min; or exercise oxygen desaturation SpO2 <75% for >1 min accompanied by symptoms or signs of hypoxemia); Symptomatic cardiovascular disease (arterial blood pressure systolic >200 mmHg, diastolic >120 mmHg, chest pain with ECG signs of cardiac ischemia); New onset neurologic impairment; Other intercurrent illness requiring medical treatment; Any discomfort leading to the wish of a patient to return to low altitude or withdraw from the study by the independent physician	Day 1 to 3 at 3'100m
Secondary	Incidence and severity of the individual components of altitude-related adverse health effects	Difference between participants receiving acetazolamide and placebo in the incidence and severity of components of altitude-related adverse health effects	Day 1 to 3 at 3'100m
Secondary	Arterial blood gases	Difference between participants receiving acetazolamide and placebo in arterial blood gases	Day 2 at 3'100 m
Secondary	Forced expiratory volume in one second (FEV1)	Difference between participants receiving acetazolamide and placebo in forced expiratory volume in one second (FEV1) measured by spirometry	Day 2 at 3'100 m
Secondary	Forced vital capacity (FVC)	Difference between participants receiving acetazolamide and placebo in forced vital capacity (FVC) measured by spirometry	Day 2 at 3'100 m
Secondary	Drug side effects	Difference between participants receiving acetazolamide and placebo in the incidence of drug side effects	Day 1 to 3 at 3'100m