Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

NCT ID: NCT01642745

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Methacholine (Provocholine) with deep inhalation

Group Type EXPERIMENTAL

Methacholine (Provocholine)

Intervention Type DRUG

two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL

Mannitol (Aridol)

Group Type EXPERIMENTAL

Mannitol (Aridol)

Intervention Type DRUG

single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).

Methacholine (Provocholine) tidal breathing

Group Type ACTIVE_COMPARATOR

Methacholine (Provocholine)

Intervention Type DRUG

two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed

Interventions

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Methacholine (Provocholine)

two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL

Intervention Type DRUG

Mannitol (Aridol)

single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* stable controlled asthma

Exclusion Criteria

* pregnancy
* use of asthma therapies other than bronchodilator therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Don Cockcroft

Professor, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Davis BE, Stewart SL, Martin AL, Cockcroft DW. Low levels of fractional exhaled nitric oxide and deep inhalation bronchoprotection are associated with mannitol non-responsiveness in asthma. Respir Med. 2014 Jun;108(6):859-64. doi: 10.1016/j.rmed.2014.03.005. Epub 2014 Mar 20.

Reference Type DERIVED
PMID: 24702886 (View on PubMed)

Other Identifiers

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IIS-A-522

Identifier Type: -

Identifier Source: org_study_id