Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
This study has been completed.
Sponsor:
University of Calgary
Information provided by (Responsible Party):
Marc Poulin, University of Calgary
ClinicalTrials.gov Identifier:
NCT01280006
First received: January 18, 2011
Last updated: December 2, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study has been designed to assess the effect of cyclooxygenase inhibition on blood pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic intermittent hypoxia exposure.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea Hypertension Cardiovascular Diseases Stroke |
Other: Intermittent hypoxia Drug: Indomethacin Drug: Celecoxib Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans |
Resource links provided by NLM:
Further study details as provided by University of Calgary:
Primary Outcome Measures:
- Arterial Blood Pressure [ Time Frame: Six weeks ] [ Designated as safety issue: No ]Blood pressure will be monitored during all three protocols.
- Cerebral Blood Flow [ Time Frame: Six weeks ] [ Designated as safety issue: No ]The cerebral blood flow will be mesauresed during each testing days of all three protocols.
Secondary Outcome Measures:
- Ventilatory Response [ Time Frame: Six weeks. ] [ Designated as safety issue: No ]The ventilatory response will be measured during each testing days of all three protocols.
- Renal Hemodynamics [ Time Frame: Six weeks ] [ Designated as safety issue: No ]The renal hemodynamics will be measured during each testing days of all three protocols.
| Enrollment: | 12 |
| Study Start Date: | January 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: Intermittent hypoxia
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. On the testing day, the subjects will undergo an acute intermittent hypoxia testing before and six hours of hypoxic chamber exposure mimicking obstructive sleep apnea syndrome.
Drug: Indomethacin
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
Indomethacin: 50 mg, Oral, three times per day for five days.
Other Name: Apo-Indomethacin
Drug: Celecoxib
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
Celecoxib: 200 mg, Oral, two times per day for five days with a visually matching sequential placebo in between of two doses.
Other Name: Celebrex
Drug: Placebo
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
Placebo: Oral, three times per day for five days.
The study will specifically evaluate:
- Cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure and homeostatic responses following chronic intermittent hypoxia exposure.
- Ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia exposure
- Evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and cyclooxygenase inhibition.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male subjects
- 18 - 45 years of age
- Informed written consent
Exclusion Criteria:
- Any history of cardio-respiratory diseases, ongoing medication, smoking, trauma, acute illnesses, collagen vascular diseases, rheumatoid arthritis, osteoarthritis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280006
Locations
| Canada, Alberta | |
| The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary | |
| Calgary, Alberta, Canada, T2N 4N1 | |
Sponsors and Collaborators
University of Calgary
Investigators
| Principal Investigator: | Marc J Poulin, PhD | University of Calgary |
More Information
No publications provided
| Responsible Party: | Marc Poulin, Prof Dr., University of Calgary |
| ClinicalTrials.gov Identifier: | NCT01280006 History of Changes |
| Other Study ID Numbers: | UC-MMHAP-COX-IH-2010001 |
| Study First Received: | January 18, 2011 |
| Last Updated: | December 2, 2011 |
| Health Authority: | Health Canada (Health Canada Clinical Trial Application, Control Number: 138344) |
Keywords provided by University of Calgary:
|
Obstructive Sleep Apnea Hypoxia Sleep Blood Pressure Hypertension Myocardial Infarction |
Stroke Ventilation Brain Cerebral Blood Flow Renal Blood Flow |
Additional relevant MeSH terms:
|
Apnea Cardiovascular Diseases Hypertension Sleep Apnea Syndromes Stroke Anoxia Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Vascular Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders |
Nervous System Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Indomethacin Celecoxib Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013