Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease

NCT03156231 | Completed Phase 4

• 1 other identifier: 2017-00137
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway disease; bronchitis; emphysema; altitude; prevention; acetazolamide

Outcome Measures

Primary Outcomes (1)

• Altitude related adverse health effects (ARAHE), cumulative incidence

  Difference between acetazolamide and placebo group in cumulative incidence of ARAHE during the stay at 3200 m. ARAHE are defined as the following: * Moderate to severe AMS (Lake Louise score ≥3 and/or Environmental Symptoms questionnaire AMSc score ≥0.7) and/or any of the following: * Severe hypoxemia (SpO2 at rest \<80% for \>30 min or \<75% for \>15 min, 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 \>110 mmHg not responding to blood pressure lowering drugs within 1 hr; chest pain with ECG signs of ischemia or new onset arrhythmia) * Withdrawal from the study by the decision of the independent physician for safetey reasons or by the patient

  Day 1 to 3 at 3200m

Secondary Outcomes (7)

• Acute mountain sickness, severity

  Day 1 to 3 at 3200m

• 6 min walk distance

  Day 2 at 760m and 3200m

• Perceived exertion

  Day 2 at 760m and 3200m

• Spirometry

  Day 2 at 760m and 3200m

• Arterial blood gases

  Day 2 at 760m and 3200m

Study Arms (2)

ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m

Drug: ACETAZOLAMIDE oral capsule

PLACEBO oral capsule

PLACEBO COMPARATOR

Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m.

Drug: Placebo oral capsule

Interventions

ACETAZOLAMIDE oral capsule DRUG

Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m

ACETAZOLAMIDE oral capsule

Placebo oral capsule DRUG

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

PLACEBO oral capsule

Eligibility Criteria

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

You may qualify if:

• Male and female patients, age 18-75 yrs.
• COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
• Born, raised and currently living at low altitude (\<800m).
• Written informed consent.

You may not qualify if:

• COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<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; OSA; 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

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

Related Publications (3)

• Schmuziger YA, Mademilov M, Buergin A, Scheiwiller PM, Mayer L, Schneider SR, Lichtblau M, Bitos K, Muralt L, Muller J, Akylbekov A, Mirzalieva G, Sooronbaev TM, Ulrich S, Bloch KE, Furian M. Nocturnal cerebral oxygenation in patients with COPD at altitude: data from a randomized clinical trial of acetazolamide. J Clin Sleep Med. 2025 Dec 1;21(12):2051-2061. doi: 10.5664/jcsm.11868.

  PMID: 41025408 DERIVED

• Christen M, Buergin A, Mademilov M, Mayer L, Schneider SR, Lichtblau M, Sooronbaev TM, Ulrich S, Bloch KE, Furian M. Electrocardiographic signs of cardiac ischemia at rest and during exercise in patients with COPD traveling to 3,100 m: data from a randomized trial of acetazolamide. Front Cardiovasc Med. 2025 Feb 6;12:1524201. doi: 10.3389/fcvm.2025.1524201. eCollection 2025.

  PMID: 39981351 DERIVED

• Furian M, Mademilov M, Buergin A, Scheiwiller PM, Mayer L, Schneider S, Emilov B, Lichtblau M, Bitos K, Muralt L, Groth A, Reiser AE, Sevik A, Sheraliev U, Marazhapov NH, Aydaralieva S, Muratbekova A, Tabyshova A, Abdraeva A, Buenzli S, Sooronbaev TM, Ulrich S, Bloch KE. Acetazolamide to Prevent Adverse Altitude Effects in COPD and Healthy Adults. NEJM Evid. 2022 Jan;1(1):EVIDoa2100006. doi: 10.1056/EVIDoa2100006. Epub 2021 Dec 22.

  PMID: 38296630 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Emphysema

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 24, 2017
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: January 29, 2019

Record last verified: 2017-06

Locations

KY (1)