Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory Disease at Altitude

NCT03177850 | Completed Phase 4

• 1 other identifier: 2017-00137D
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

sleep related breathing disturbances; respiratory polygraphy; airway disease; emphysema; acetazolamide; altitude; nocturnal pulse oxymetry

Outcome Measures

Primary Outcomes (2)

• Change in nocturnal oxygen saturation

  Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

  night 1 at 760m and night 1 at 3200 m

• Change in nocturnal oxygen desaturation index

  Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

  night 1 at 760m and night 1 at 3200 m

Secondary Outcomes (5)

• Change in nocturnal oxygen saturation

  night 1 at 760m and night 2 at 3200 m

• Change in nocturnal oxygen desaturation index

  night 1 at 760m and night 2 at 3200 m

• Change in apnea/hypopnea index

  night 1 at 760m and night 1 at 3200 m

• Change in apnea/hypopnea index

  night 1 at 760m and night 2 at 3200 m

• Change in subjective sleepiness and sleep quality

  Day 1 and 2 at 760m and 3200m

Study Arms (2)

ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

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

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 3200m until the morning after the second night at 3200m.

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 3200m

ACETAZOLAMIDE oral capsule

Placebo oral capsule DRUG

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

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, 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/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

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; Emphysema

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; 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 of Zurich

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

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 23, 2017
• First Posted: June 6, 2017
• Study Start: May 24, 2017
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: January 29, 2019

Record last verified: 2017-10

Locations

KY (1)