Salbutamol Tolerance Onset

NCT ID: NCT01338311

Last Updated: 2012-07-20

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.

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

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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salbutamol

Group Type ACTIVE_COMPARATOR

salbutamol

Intervention Type DRUG

200mcg twice daily for a total of 7 doses

placebo

200mcg twice daily for a total of 7 doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

200mcg twice a day for a total of 7 doses (3.5 days).

Interventions

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salbutamol

200mcg twice daily for a total of 7 doses

Intervention Type DRUG

Placebo

200mcg twice a day for a total of 7 doses (3.5 days).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female
* 18 to 65 years of age
* non smoker
* beta agonist naive for at least 14 days
* baseline FEV1 at least 70% predicted
* no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1

Exclusion Criteria

* poorly controlled asthma
* pregnant or lactating women
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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Responsibility Role SPONSOR

Principal Investigators

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Donald W Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Stewart SL, Martin AL, Davis BE, Cockcroft DW. Salbutamol tolerance to bronchoprotection: course of onset. Ann Allergy Asthma Immunol. 2012 Dec;109(6):454-7. doi: 10.1016/j.anai.2012.08.003. Epub 2012 Aug 22.

Reference Type DERIVED
PMID: 23176887 (View on PubMed)

Other Identifiers

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BMC 10-226

Identifier Type: -

Identifier Source: org_study_id