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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

January 18, 2011
December 2, 2011
January 2011
December 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01280006 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Obstructive Sleep Apnea
  • Hypertension
  • Cardiovascular Diseases
  • Stroke
  • 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.

Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01280006
UC-MMHAP-COX-IH-2010001
Yes
Marc Poulin, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Marc J Poulin, PhD University of Calgary
University of Calgary
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP