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Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01642745
First received: January 17, 2012
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.

Condition Intervention Phase
Asthma
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable controlled asthma

Exclusion Criteria:

  • pregnancy
  • use of asthma therapies other than bronchodilator therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642745

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Don Cockcroft, Professor, College of Medicine, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01642745     History of Changes
Other Study ID Numbers: IIS-A-522 
Study First Received: January 17, 2012
Last Updated: October 26, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Methacholine Chloride
Mannitol
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Diuretics, Osmotic
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on December 02, 2016