Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD

NCT04913389 | Unknown Phase 3

• 1 other identifier: 01-2021-KEB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Altitude Sickness; Altitude Hypoxia

Keywords

Acetazolamide; Mountain sickness; Hypoxemia; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence and severity of the individual components of altitude-related adverse health effects

  Day 1 to 3 at 3'100m

• Arterial blood gases

  Day 2 at 3'100 m

• Forced expiratory volume in one second (FEV1)

  Day 2 at 3'100 m

• Forced vital capacity (FVC)

  Day 2 at 3'100 m

• Drug side effects

  Day 1 to 3 at 3'100m

Study Arms (2)

Acetazolamide

ACTIVE COMPARATOR

Acetazolamide (oral capsules)

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

Placebo (oral capsules)

Drug: Placebo

Interventions

Acetazolamide 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.

Also known as: Acetazolamide, oral capsule

Acetazolamide

Placebo 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.

Also known as: Placebo, oral capsule

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine, Kyrgyz Republic: collaborator

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Altitude Sickness; Hypoxia

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Konrad E Bloch

  University Hospital, Zürich, Switzerland

  STUDY CHAIR

• Talant M Sooronbaev

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

• Michael Furian

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, placebo-controlled, double-blind

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 4, 2021
• Study Start: June 1, 2021
• Primary Completion: August 10, 2022
• Study Completion: December 31, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

KY (1)