Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness
This study is currently recruiting participants.
Verified July 2012 by University of Saskatchewan
Sponsor:
University of Saskatchewan
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01642745
First received: January 17, 2012
Last updated: July 13, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642745
Contacts
| Contact: Beth E Davis, PhD | 3069668291 | beth.davis@usask.ca |
Locations
| Canada, Saskatchewan | |
| University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N0W8 | |
| Contact: Beth Davis, PhD 3069668291 beth.davis@usask.ca | |
| Principal Investigator: Donald W Cockcroft, MD | |
| Sub-Investigator: Beth E Davis, PhD | |
Sponsors and Collaborators
University of Saskatchewan
More Information
No publications provided
| Responsible Party: | 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: | July 13, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mannitol Methacholine Chloride Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses 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 |
ClinicalTrials.gov processed this record on May 22, 2013