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:
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
  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:
    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.

Detailed Description:

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

Additional relevant MeSH terms:
Brain Diseases
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
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 April 16, 2014