Effects of Caffeine on Methacholine Challenge and Exhaled Nitric Oxide Levels.

This study has been completed.

Sponsor:

Information provided by:

University of Saskatchewan

ClinicalTrials.gov Identifier:

NCT01057875

First received: January 26, 2010

Last updated: October 5, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2010

Last Updated Date

October 5, 2010

Start Date ^ICMJE

January 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

methacholine pc20 [ Time Frame: 1 hour post ingestion ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01057875 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Caffeine on Methacholine Challenge and Exhaled Nitric Oxide Levels.

Official Title ^ICMJE

The Effects of Caffeine on Exhaled Nitric Oxide Levels and Methacholine PC20

Brief Summary

To investigate whether or not the ingestion of caffeine with alter airway responsiveness to methacholine and/or change the level of exhaled nitric oxide.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Other: caffeine
Starbuck's Grande Pike Roast coffee
Other: No caffeine
Starbuck's Grande Pike Roast Decaffeinated Coffee

Study Arm (s)

Experimental: coffee with caffeine
Intervention: Other: caffeine
Placebo Comparator: decaffeinated coffee
Starbuck's Grande Pike Roast Decaf

Intervention: Other: No caffeine

Publications *

Yurach MT, Davis BE, Cockcroft DW. The effect of caffeinated coffee on airway response to methacholine and exhaled nitric oxide. Respir Med. 2011 Nov;105(11):1606-10. Epub 2011 Jul 2.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

clinical diagnosis of asthma
FEV1 greater than 65%

Exclusion Criteria:

asthma is poorly controlled
presence of other airway disease (e.g. COPD)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01057875

Other Study ID Numbers ^ICMJE

BIO REB 09-186

Has Data Monitoring Committee

Responsible Party

Donald Cockcroft, MD, University of Saskatchewan

Study Sponsor ^ICMJE

University of Saskatchewan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Donald W Cockcroft, MD

University of Saskatchewan

Information Provided By

University of Saskatchewan

Verification Date

October 2010

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

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