Effects of Caffeine on Methacholine Challenge and Exhaled... | NCT01057875

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

NCT01057875

Sponsor

University of Saskatchewan

Status

Completed

Last Update Posted

Oct 7, 2010Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Asthma

Interventions

caffeine
No caffeine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jan 26, 2010

First Submission Date that Met QC Criteria

Jan 26, 2010

First Posted Date

Jan 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2010

Last Update Posted Date

Oct 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
coffee with caffeine	Experimental		Other: caffeine
decaffeinated coffee	Placebo Comparator	Starbuck's Grande Pike Roast Decaf	Other: No caffeine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
caffeine	Other	Starbuck's Grande Pike Roast coffee	coffee with caffeine

Measure	Description	Time Frame
methacholine pc20		1 hour post ingestion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of asthma
FEV1 greater than 65%

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald W Cockcroft, MD	University of Saskatchewan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Saskatchewan		Saskatoon	Saskatchewan	S7N 0W8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21726992	Derived	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. doi: 10.1016/j.rmed.2011.06.006. Epub 2011 Jul 2.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones