Clinical trial NCT04913389: Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD
Official title: Novel Approach to Prevention of Altitude-related Illness in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Altitude Sickness
Altitude Hypoxia
Keywords: Acetazolamide
Mountain sickness
Hypoxemia
Prevention
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine, Kyrgyz Republic
First posted: 2021-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, placebo-controlled, double-blind
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Incidence of altitude-related adverse health effects
timeFrame: Day 1 to 3 at 3'100m
Secondary outcomes:
measure: Incidence and severity of the individual components of altitude-related adverse health effects
timeFrame: Day 1 to 3 at 3'100m
measure: Arterial blood gases
timeFrame: Day 2 at 3'100 m
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Day 2 at 3'100 m
measure: Forced vital capacity (FVC)
timeFrame: Day 2 at 3'100 m
measure: Drug side effects
timeFrame: Day 1 to 3 at 3'100m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich, Switzerland
name: Konrad E Bloch
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev
role: STUDY_DIRECTOR
affiliation: University Hospital, Zürich
name: Michael Furian
role: PRINCIPAL_INVESTIGATOR
References: