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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02450968 |
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Date of registration:
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18/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Altitude Related Illness In Patients With Respiratory Disease
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Scientific title:
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Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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124 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02450968 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Kyrgyzstan
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Contacts
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Name:
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Talant M Sooronbaev, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan |
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Name:
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Konrad E Bloch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Zürich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
- Living at low altitude (<800m)
Exclusion Criteria:
- 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
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease (COPD)
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Intervention(s)
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Drug: Dexamethasone
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Drug: Placebo
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Primary Outcome(s)
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Acute mountain sickness, cumulative incidence
[Time Frame: day 3 at 3200 m]
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Secondary Outcome(s)
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Arterial blood gases
[Time Frame: Day 2 at 3200 m]
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Acute mountain sickness, severity
[Time Frame: day 1, day 2, day 3 at 3200 m]
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Perceived exertion
[Time Frame: Day 2 at 3200 m]
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6 min walk distance
[Time Frame: Day 2 at 3200 m]
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Severe hypoxemia
[Time Frame: day 1 to 3 at 3200m]
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Spirometry
[Time Frame: Day 2 at 3200 m]
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Secondary ID(s)
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EK15-2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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