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CompletedNCT01338311Updated Jul 20, 2012

Salbutamol Tolerance Onset

A Phase 4 interventional study of salbutamol and Placebo in Asthma, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-07-20.

Sponsored by University of Saskatchewan · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Asthma
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In context

Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • poorly controlled asthma
  • pregnant or lactating women
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    salbutamol

    Drug: salbutamol

  • Placebo comparator
    placebo

    200mcg twice daily for a total of 7 doses

    Drug: Placebo

Interventions

  • Drugsalbutamol

    200mcg twice daily for a total of 7 doses

  • DrugPlacebo

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

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What researchers measure

Primary outcomes

  1. Airway responsiveness as a measure of salbutamol bronchoprotection

    Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.

    Time frame: ten minutes post 200mcg salbutamol on day 1

  2. Airway responsiveness as a measure of salbutamol bronchoprotection

    Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.

    Time frame: ten minutes post 200mcg salbutamol on day 3

  3. Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance.

    Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.

    Time frame: ten minutes post 200mcg salbutamol on day 5

  4. Airway responsiveness as a measure of salbutamol bronchoprotection

    Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.

    Time frame: ten minutes post 200mcg salbutamol on day 7

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Study locations

1 site
  • University of Saskatchewan
    Saskatoon, Saskatchewan S7N 0W8, Canada
08

References and documents

Publications

  • 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. PubMed 23176887 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01338311
Lead sponsor
University of Saskatchewan
Responsible party
Sponsor
First posted
Apr 19, 2011
Start date
Mar 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Jul 20, 2012

Study contacts

Donald W Cockcroft, MD
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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