Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans

NCT ID: NCT01280006

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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The study will specifically evaluate:

1. Cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure and homeostatic responses following chronic intermittent hypoxia exposure.
2. Ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia exposure
3. Evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and cyclooxygenase inhibition.

Conditions

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Obstructive Sleep Apnea Hypertension Cardiovascular Diseases Stroke

Keywords

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Obstructive Sleep Apnea Hypoxia Sleep Blood Pressure Hypertension Myocardial Infarction Stroke Ventilation Brain Cerebral Blood Flow Renal Blood Flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Apo-Indomethacin Celebrex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Marc Poulin

Prof Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc J Poulin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Beaudin AE, Pun M, Yang C, Nicholl DD, Steinback CD, Slater DM, Wynne-Edwards KE, Hanly PJ, Ahmed SB, Poulin MJ. Cyclooxygenases 1 and 2 differentially regulate blood pressure and cerebrovascular responses to acute and chronic intermittent hypoxia: implications for sleep apnea. J Am Heart Assoc. 2014 May 9;3(3):e000875. doi: 10.1161/JAHA.114.000875.

Reference Type DERIVED
PMID: 24815497 (View on PubMed)

Other Identifiers

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UC-MMHAP-COX-IH-2010001

Identifier Type: -

Identifier Source: org_study_id