Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness
Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations
1 other identifier
interventional
20
1 country
1
Brief Summary
The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Nov 2011
1 active site
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
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedOctober 27, 2016
October 1, 2016
1.3 years
January 17, 2012
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing
The two minute tidal breathing PC20 with be captured once at visit 1.
Visit 1 (Day 1)
airway responsiveness (PD15) to inhaled mannitol
The PD15 to mannitol will be captured once at either visit 2 or visit 3.
Visit 2 = up to 13 days
Airway responsiveness (PC20) to deep inhalation methacholine
The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.
Visit 3 = up to 14 days
Study Arms (3)
Methacholine (Provocholine) with deep inhalation
EXPERIMENTALMannitol (Aridol)
EXPERIMENTALMethacholine (Provocholine) tidal breathing
ACTIVE COMPARATORInterventions
two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL
single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).
Eligibility Criteria
You may qualify if:
- stable controlled asthma
You may not qualify if:
- pregnancy
- use of asthma therapies other than bronchodilator therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Saskatchewan
Saskatoon, Saskatchewan, S7N0W8, Canada
Related Publications (1)
Davis BE, Stewart SL, Martin AL, Cockcroft DW. Low levels of fractional exhaled nitric oxide and deep inhalation bronchoprotection are associated with mannitol non-responsiveness in asthma. Respir Med. 2014 Jun;108(6):859-64. doi: 10.1016/j.rmed.2014.03.005. Epub 2014 Mar 20.
PMID: 24702886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, College of Medicine
Study Record Dates
First Submitted
January 17, 2012
First Posted
July 17, 2012
Study Start
November 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
October 27, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share