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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 4

Locations

Kyrgyzstan

Study Type

Interventional

Intervention

ACETAZOLAMIDE oral capsule

Placebo oral capsule

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring prevention, acetazolamide, obstructive airway disease, lung water

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

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

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

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.

Outcomes

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

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

Full Information

NCT ID

NCT03540901

First Posted

May 15, 2018

Last Updated

November 4, 2021

Sponsor

University of Zurich

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03540901

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 22, 2018 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

prevention, acetazolamide, obstructive airway disease, lung water

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACETAZOLAMIDE oral capsule

Arm Type

Active Comparator

Arm Description

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

Arm Title

PLACEBO oral capsule

Arm Type

Placebo Comparator

Arm Description

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 3100m

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 3100m

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 2 at 760m and 3100m

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 2 at 3100m

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

First Name & Middle Initial & Last Name & Degree

Michael Furian, MSc

Organizational Affiliation

University Hospital, Zürich

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Silvia Ulrich, MD

Organizational Affiliation

University Hospital, Zürich

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Center of Cardiology and Internal Medicine

City

Biskek

ZIP/Postal Code

720040

Country

Kyrgyzstan

12. IPD Sharing Statement

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

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