Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

October 26, 2016 updated by: Don Cockcroft, University of Saskatchewan

Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations

The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N0W8
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable controlled asthma

Exclusion Criteria:

  • pregnancy
  • use of asthma therapies other than bronchodilator therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Visit 1 (Day 1)
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.
Visit 2 = up to 13 days
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.
Visit 3 = up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIS-A-522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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