Effect of Acetazolamide on Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT03540901

Collaborator

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov (Other)

112

Enrollment

Location

Arms

2.4

Actual Duration (Months)

47.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound at acute altitude exposure in patients with Chronic Obstructive Pulmonary Disease (COPD).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: ACETAZOLAMIDE oral capsule Drug: Placebo oral capsule	Phase 4

Detailed Description

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound 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 (3100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3100 m.

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Acetazolamide on Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial

Actual Study Start Date :

May 22, 2018

Actual Primary Completion Date :

Aug 2, 2018

Actual Study Completion Date :

Aug 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ACETAZOLAMIDE oral capsule 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3100m until the morning after the second night at 3100m	Drug: ACETAZOLAMIDE oral capsule Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3100m
Placebo Comparator: PLACEBO oral capsule Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3100m until the morning after the second night at 3100m.	Drug: Placebo oral capsule Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3100m

Arm

Intervention/Treatment

Active Comparator: ACETAZOLAMIDE oral capsule

375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3100m until the morning after the second night at 3100m

Drug: ACETAZOLAMIDE oral capsule

Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3100m

Placebo Comparator: PLACEBO oral capsule

Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3100m until the morning after the second night at 3100m.

Drug: Placebo oral capsule

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3100m

Outcome Measures

Primary Outcome Measures

Difference in change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group [Day 2 at 760m and 3100m]
Difference in change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group

Secondary Outcome Measures

Change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide and in the placebo group, respectively [Day 2 at 3100m]
Change of ultrasound lung comets from 760 m baseline measurement to measurement at 3100 m in the acetazolamide and in the placebo group, respectively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female patients, age 18-75 yrs.
COPD diagnosed according to GOLD, FEV1 40-80% predicted, Oxygen Saturation (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/Forced Vital Capacity <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; obstructive sleep apnea; 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Center of Cardiology and Internal Medicine	Biskek		Kyrgyzstan	720040

Sponsors and Collaborators

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

Investigators

Study Chair: Konrad E Bloch, MD, University Hospital, Zürich
Study Director: Talant M Sooronbaev, MD, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Principal Investigator: Michael Furian, MSc, University Hospital, Zürich
Principal Investigator: Silvia Ulrich, MD, University Hospital, Zürich