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NCT Number: NCT03156231

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Bronchial Diseases Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

About this study

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

ACETAZOLAMIDE oral capsule

Drug

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

Placebo oral capsule

Drug

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

Primary outcomes

  1. Altitude related adverse health effects (ARAHE), cumulative incidence

    Time frame: Day 1 to 3 at 3200m

    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

Secondary outcomes

  1. Acute mountain sickness, severity

    Time frame: Day 1 to 3 at 3200m

    Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.

  2. 6 min walk distance

    Time frame: Day 2 at 760m and 3200m

    Difference in altitude-induced change in the distance walked in 6 min between the acetazolamide and placebo group.

  3. Perceived exertion

    Time frame: Day 2 at 760m and 3200m

    Difference in altitude-induced change in the perceived exertion rated with the Borg CR10 scale between the acetazolamide and placebo group

  4. Spirometry

    Time frame: Day 2 at 760m and 3200m

    Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group

  5. Arterial blood gases

    Time frame: Day 2 at 760m and 3200m

    Difference in altitude-induced change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the acetazolamide and placebo group

  6. Exercise endurance during constant load cycling ergometry

    Time frame: Day 3 at 760m and 3200m

    Difference in altitude-induced change in exercise endurance between acetazolamide and placebo group, measured by constant load cycling ergometry

  7. Side effects

    Time frame: Day 1 to 3 at 3200m

    Difference between acetazolamide and placebo group in the cumulative incidence of medication side effects during the stay at 3200 m.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Registry information

Official study title

Acetazolamide for Prevention of Altitude Related Illness in Patients With Chronic Obstructive Pulmonary Disease (COPD). Randomized, Placebo-Controlled, Double-Blind Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 17, 2017
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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