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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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28 December 2015 |
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Main ID: |
NCT02450994 |
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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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Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude
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Scientific title:
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Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) 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/NCT02450994 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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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:
Both
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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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Mean nocturnal oxygen saturation measured by pulse oximetry
[Time Frame: night 1 at 3200 m]
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Secondary Outcome(s)
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Apnea/hypopnea index
[Time Frame: night 1 at 700 m]
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Apnea/hypopnea index
[Time Frame: night 2 at 3200 m]
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Mean nocturnal oxygen saturation measured by pulse oximetry
[Time Frame: night 2 at 3200 m]
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Oxygen desaturation index
[Time Frame: night 1 at 700 m]
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Subjective sleepiness
[Time Frame: day 2 at 700 m]
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Subjective sleepiness
[Time Frame: day 2 at 3200 m]
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Apnea/hypopnea index
[Time Frame: night 1 at 3200 m]
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Psychomotor vigilance test reaction time
[Time Frame: day 2 at 700 m]
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Mean nocturnal oxygen saturation measured by pulse oximetry
[Time Frame: night 1 at 700 m]
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Oxygen desaturation index
[Time Frame: night 1 at 3200 m]
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Oxygen desaturation index
[Time Frame: night 2 at 3200 m]
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Secondary ID(s)
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EK15-2015_V1
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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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