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

NCT03540901 | Completed Phase 4

• 1 other identifier: 2017-00137G
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

prevention; acetazolamide; obstructive airway disease; lung water

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (1)

• 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

Study Arms (2)

ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

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

PLACEBO oral capsule

PLACEBO COMPARATOR

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

Interventions

ACETAZOLAMIDE oral capsule DRUG

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

ACETAZOLAMIDE oral capsule

Placebo oral capsule DRUG

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

PLACEBO oral capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

• Michael Furian, MSc

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

• Silvia Ulrich, MD

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 30, 2018
• Study Start: May 22, 2018
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: November 5, 2021

Record last verified: 2021-11

Locations

KY (1)