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Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

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ClinicalTrials.gov Identifier: NCT01642745
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.

Condition or disease Intervention/treatment Phase
Asthma Drug: Methacholine (Provocholine) Drug: Mannitol (Aridol) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations
Study Start Date : November 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing [ Time Frame: Visit 1 (Day 1) ]
    The two minute tidal breathing PC20 with be captured once at visit 1.

  2. airway responsiveness (PD15) to inhaled mannitol [ Time Frame: Visit 2 = up to 13 days ]
    The PD15 to mannitol will be captured once at either visit 2 or visit 3.

  3. Airway responsiveness (PC20) to deep inhalation methacholine [ Time Frame: Visit 3 = up to 14 days ]
    The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • stable controlled asthma

Exclusion Criteria:

  • pregnancy
  • use of asthma therapies other than bronchodilator therapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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