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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156231
• Other study ID #: 2017-00137
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: June 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• ACETAZOLAMIDE oral capsule
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
• Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

Locations

Country	Name	City	State
Kyrgyzstan	National Center of Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyzstan

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute mountain sickness, severity	Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.	Day 1 to 3 at 3200m
Secondary	6 min walk distance	Difference in altitude-induced change in the distance walked in 6 min between the acetazolamide and placebo group.	Day 2 at 760m and 3200m
Secondary	Perceived exertion	Difference in altitude-induced change in the perceived exertion rated with the Borg CR10 scale between the acetazolamide and placebo group	Day 2 at 760m and 3200m
Secondary	Spirometry	Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group	Day 2 at 760m and 3200m
Secondary	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	Day 2 at 760m and 3200m
Secondary	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	Day 3 at 760m and 3200m
Secondary	Side effects	Difference between acetazolamide and placebo group in the cumulative incidence of medication side effects during the stay at 3200 m.	Day 1 to 3 at 3200m