Back to resultsEffect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 4
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
ACETAZOLAMIDE oral capsule
Placebo oral capsule
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring airway disease, bronchitis, emphysema, altitude, prevention, acetazolamide
Eligibility Criteria
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
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 oral capsule
PLACEBO oral capsule
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Acute mountain sickness, severity
Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.
6 min walk distance
Difference in altitude-induced change in the distance walked in 6 min between the acetazolamide and placebo group.
Perceived exertion
Difference in altitude-induced change in the perceived exertion rated with the Borg CR10 scale between the acetazolamide and placebo group
Spirometry
Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group
Arterial blood gases
Difference in altitude-induced change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the acetazolamide and placebo group
Exercise endurance during constant load cycling ergometry
Difference in altitude-induced change in exercise endurance between acetazolamide and placebo group, measured by constant load cycling ergometry
Side effects
Difference between acetazolamide and placebo group in the cumulative incidence of medication side effects during the stay at 3200 m.
Full Information
NCT ID
NCT03156231
First Posted
May 15, 2017
Last Updated
January 26, 2019
Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
1. Study Identification
Unique Protocol Identification Number
NCT03156231
Brief Title
Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease
Official Title
Acetazolamide for Prevention of Altitude Related Illness in Patients With Chronic Obstructive Pulmonary Disease (COPD). Randomized, Placebo-Controlled, Double-Blind Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
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
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
airway disease, bronchitis, emphysema, altitude, prevention, acetazolamide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACETAZOLAMIDE oral capsule
Arm Type
Active Comparator
Arm Description
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
Arm Title
PLACEBO oral capsule
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ACETAZOLAMIDE oral capsule
Intervention Description
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Primary Outcome Measure Information:
Title
Altitude related adverse health effects (ARAHE), cumulative incidence
Description
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
Time Frame
Day 1 to 3 at 3200m
Secondary Outcome Measure Information:
Title
Acute mountain sickness, severity
Description
Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.
Time Frame
Day 1 to 3 at 3200m
Title
6 min walk distance
Description
Difference in altitude-induced change in the distance walked in 6 min between the acetazolamide and placebo group.
Time Frame
Day 2 at 760m and 3200m
Title
Perceived exertion
Description
Difference in altitude-induced change in the perceived exertion rated with the Borg CR10 scale between the acetazolamide and placebo group
Time Frame
Day 2 at 760m and 3200m
Title
Spirometry
Description
Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group
Time Frame
Day 2 at 760m and 3200m
Title
Arterial blood gases
Description
Difference in altitude-induced change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the acetazolamide and placebo group
Time Frame
Day 2 at 760m and 3200m
Title
Exercise endurance during constant load cycling ergometry
Description
Difference in altitude-induced change in exercise endurance between acetazolamide and placebo group, measured by constant load cycling ergometry
Time Frame
Day 3 at 760m and 3200m
Title
Side effects
Description
Difference between acetazolamide and placebo group in the cumulative incidence of medication side effects during the stay at 3200 m.
Time Frame
Day 1 to 3 at 3200m
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Talant M Sooronbaev, MD
Organizational Affiliation
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Official's Role
Study Director
Facility Information:
Facility Name
National Center of Cardiology and Internal Medicine
City
Bishkek
ZIP/Postal Code
720040
Country
Kyrgyzstan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease
We'll reach out to this number within 24 hrs