NCT02450994

Brief Summary

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

May 18, 2015

Last Update Submit

December 18, 2015

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway diseasebronchitisemphysemalungtreatmentsleep

Outcome Measures

Primary Outcomes (1)

  • Mean nocturnal oxygen saturation measured by pulse oximetry

    Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group

    night 1 at 3200 m

Secondary Outcomes (11)

  • Oxygen desaturation index

    night 1 at 3200 m

  • Mean nocturnal oxygen saturation measured by pulse oximetry

    night 2 at 3200 m

  • Apnea/hypopnea index

    night 2 at 3200 m

  • Apnea/hypopnea index

    night 1 at 3200 m

  • Oxygen desaturation index

    night 2 at 3200 m

  • +6 more secondary outcomes

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 4 mg capsules, twice per day, orally

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo capsules twice per day, orally

Drug: Placebo

Interventions

DexamethasoneDRUG
Dexamethasone
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
  • Living at low altitude (\<800m)

You may not qualify if:

  • COPD exacerbation
  • severe COPD, GOLD grade 3 or 4
  • arterial oxygen saturation \<92% at low altitude (\<800 m)
  • Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea.
  • Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day).
  • pregnant or nursing patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

Related Publications (1)

  • Furian M, Lichtblau M, Aeschbacher SS, Estebesova B, Emilov B, Sheraliev U, Marazhapov NH, Mademilov M, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190067. doi: 10.1001/jamanetworkopen.2019.0067.

    PMID: 30794302DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitisEmphysema

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

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

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 18, 2015

First Posted

May 21, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 21, 2015

Record last verified: 2015-12

Locations

KY(1)