Back to resultsAcetazolamide to Prevent Impending Altitude-illness in Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, Altitude Sickness, Altitude Hypoxia
Status
Active
Phase
Phase 3
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring Acetazolamide, Mountain sickness, Hypoxemia, Prevention
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.
Sites / Locations
- National Center of Cardiology and Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acetazolamide
Placebo
Arm Description
Acetazolamide (oral capsules)
Placebo (oral capsules)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Arterial blood gases
Difference between participants receiving acetazolamide and placebo in arterial blood gases
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
Forced vital capacity (FVC)
Difference between participants receiving acetazolamide and placebo in forced vital capacity (FVC) measured by spirometry
Drug side effects
Difference between participants receiving acetazolamide and placebo in the incidence of drug side effects
Full Information
NCT ID
NCT04913389
First Posted
May 23, 2021
Last Updated
March 2, 2023
Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine, Kyrgyz Republic
1. Study Identification
Unique Protocol Identification Number
NCT04913389
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine, Kyrgyz Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Altitude Sickness, Altitude Hypoxia
Keywords
Acetazolamide, Mountain sickness, Hypoxemia, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized, placebo-controlled, double-blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
Acetazolamide (oral capsules)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (oral capsules)
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Acetazolamide, oral capsule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo, oral capsule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of altitude-related adverse health effects
Description
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
Time Frame
Day 1 to 3 at 3'100m
Secondary Outcome Measure Information:
Title
Incidence and severity of the individual components of altitude-related adverse health effects
Description
Difference between participants receiving acetazolamide and placebo in the incidence and severity of components of altitude-related adverse health effects
Time Frame
Day 1 to 3 at 3'100m
Title
Arterial blood gases
Description
Difference between participants receiving acetazolamide and placebo in arterial blood gases
Time Frame
Day 2 at 3'100 m
Title
Forced expiratory volume in one second (FEV1)
Description
Difference between participants receiving acetazolamide and placebo in forced expiratory volume in one second (FEV1) measured by spirometry
Time Frame
Day 2 at 3'100 m
Title
Forced vital capacity (FVC)
Description
Difference between participants receiving acetazolamide and placebo in forced vital capacity (FVC) measured by spirometry
Time Frame
Day 2 at 3'100 m
Title
Drug side effects
Description
Difference between participants receiving acetazolamide and placebo in the incidence of drug side effects
Time Frame
Day 1 to 3 at 3'100m
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch
Organizational Affiliation
University Hospital, Zürich, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Talant M Sooronbaev
Organizational Affiliation
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Furian
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center of Cardiology and Internal Medicine
City
Bishkek
ZIP/Postal Code
720040
Country
Kyrgyzstan
12. IPD Sharing Statement
Learn more about this trial
Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD
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