Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

This study has been completed.
Information provided by (Responsible Party):
University of Saskatchewan Identifier:
First received: January 17, 2012
Last updated: December 10, 2013
Last verified: October 2013
The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.

Condition Intervention Phase
Drug: Methacholine (Provocholine)
Drug: Mannitol (Aridol)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations

Resource links provided by NLM:

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing [ Time Frame: Visit 1 (Day 1) ] [ Designated as safety issue: No ]
    The two minute tidal breathing PC20 with be captured once at visit 1.

  • airway responsiveness (PD15) to inhaled mannitol [ Time Frame: Visit 2 = up to 13 days ] [ Designated as safety issue: No ]
    The PD15 to mannitol will be captured once at either visit 2 or visit 3.

  • Airway responsiveness (PC20) to deep inhalation methacholine [ Time Frame: Visit 3 = up to 14 days ] [ Designated as safety issue: No ]
    The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.

Enrollment: 20
Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methacholine (Provocholine) with deep inhalation Drug: Methacholine (Provocholine)
two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL
Experimental: Mannitol (Aridol) Drug: Mannitol (Aridol)
single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).
Active Comparator: Methacholine (Provocholine) tidal breathing Drug: Methacholine (Provocholine)
two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • stable controlled asthma

Exclusion Criteria:

  • pregnancy
  • use of asthma therapies other than bronchodilator therapy
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Please refer to this study by its identifier: NCT01642745

Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N0W8
Sponsors and Collaborators
University of Saskatchewan
  More Information

No publications provided by University of Saskatchewan

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Saskatchewan Identifier: NCT01642745     History of Changes
Other Study ID Numbers: IIS-A-522 
Study First Received: January 17, 2012
Last Updated: December 10, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Methacholine Chloride
Autonomic Agents
Bronchoconstrictor Agents
Cardiovascular Agents
Cholinergic Agents
Cholinergic Agonists
Diuretics, Osmotic
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on February 04, 2016