NCT01057875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

Enrollment Period

1 month

First QC Date

January 26, 2010

Last Update Submit

October 5, 2010

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • methacholine pc20

    1 hour post ingestion

Study Arms (2)

coffee with caffeine

EXPERIMENTAL
Other: caffeine

decaffeinated coffee

PLACEBO COMPARATOR

Starbuck's Grande Pike Roast Decaf

Other: No caffeine

Interventions

caffeineOTHER

Starbuck's Grande Pike Roast coffee

coffee with caffeine
No caffeineOTHER

Starbuck's Grande Pike Roast Decaffeinated Coffee

decaffeinated coffee

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of asthma
  • FEV1 greater than 65%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21726992DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Donald W Cockcroft, MD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 7, 2010

Record last verified: 2010-10

Locations

CA(1)