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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280006
• Other study ID #: UC-MMHAP-COX-IH-2010001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 18, 2011
• Last updated: December 2, 2011
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Health Canada (Health Canada Clinical Trial Application, Control Number: 138344)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Blood Pressure	Blood pressure will be monitored during all three protocols.	Six weeks	No
Primary	Cerebral Blood Flow	The cerebral blood flow will be mesauresed during each testing days of all three protocols.	Six weeks	No
Secondary	Ventilatory Response	The ventilatory response will be measured during each testing days of all three protocols.	Six weeks.	No
Secondary	Renal Hemodynamics	The renal hemodynamics will be measured during each testing days of all three protocols.	Six weeks	No