NCT02450968

Brief Summary

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute mountain sickness 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

May 18, 2015

Last Update Submit

May 16, 2017

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway diseasebronchitisemphysemalungtreatment

Outcome Measures

Primary Outcomes (1)

  • Acute mountain sickness, cumulative incidence

    Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score \>=0.7)

    day 3 at 3200 m

Secondary Outcomes (6)

  • Severe hypoxemia

    day 1 to 3 at 3200m

  • Acute mountain sickness, severity

    day 1, day 2, day 3 at 3200 m

  • 6 min walk distance

    Day 2 at 3200 m

  • Perceived exertion

    Day 2 at 3200 m

  • Spirometry

    Day 2 at 3200 m

  • +1 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 (3)

  • Preiss H, Mayer L, Furian M, Schneider SR, Muller J, Saxer S, Mademilov M, Titz A, Shehab A, Reimann L, Sooronbaev T, Tanner FC, Bloch KE, Ulrich S, Lichtblau M. Right ventricular strain impairment due to hypoxia in patients with COPD: a post hoc analysis of two randomised controlled trials. Open Heart. 2025 Jan 4;12(1):e002837. doi: 10.1136/openhrt-2024-002837.

    PMID: 39756820DERIVED

  • Muralt L, Furian M, Lichtblau M, Aeschbacher SS, Clark RA, Estebesova B, Sheraliev U, Marazhapov N, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Postural Control in Lowlanders With COPD Traveling to 3100 m: Data From a Randomized Trial Evaluating the Effect of Preventive Dexamethasone Treatment. Front Physiol. 2018 Jun 22;9:752. doi: 10.3389/fphys.2018.00752. eCollection 2018.

    PMID: 29988503DERIVED

  • 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. Efficacy of Dexamethasone in Preventing Acute Mountain Sickness in COPD Patients: Randomized Trial. Chest. 2018 Oct;154(4):788-797. doi: 10.1016/j.chest.2018.06.006. Epub 2018 Jul 10.

    PMID: 29909285DERIVED

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

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

KY(1)