- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057875
Effects of Caffeine on Methacholine Challenge and Exhaled Nitric Oxide Levels.
October 5, 2010 updated by: University of Saskatchewan
The Effects of Caffeine on Exhaled Nitric Oxide Levels and Methacholine PC20
To investigate whether or not the ingestion of caffeine with alter airway responsiveness to methacholine and/or change the level of exhaled nitric oxide.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 0W8
- University of Saskatchewan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- clinical diagnosis of asthma
- FEV1 greater than 65%
Exclusion Criteria:
- asthma is poorly controlled
- presence of other airway disease (e.g. COPD)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: coffee with caffeine
|
Starbuck's Grande Pike Roast coffee
|
|
Placebo Comparator: decaffeinated coffee
Starbuck's Grande Pike Roast Decaf
|
Starbuck's Grande Pike Roast Decaffeinated Coffee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
methacholine pc20
Time Frame: 1 hour post ingestion
|
1 hour post ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 26, 2010
First Submitted That Met QC Criteria
January 26, 2010
First Posted (Estimate)
January 27, 2010
Study Record Updates
Last Update Posted (Estimate)
October 7, 2010
Last Update Submitted That Met QC Criteria
October 5, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO REB 09-186
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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