Salbutamol Tolerance Onset

University of Saskatchewan

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Placebo; Drug: salbutamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01338311

BMC 10-226

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

15 participants in 2 patient groups, including a placebo group

salbutamol

Active Comparator group

Treatment:

Drug: salbutamol

placebo

Placebo Comparator group

Description:

200mcg twice daily for a total of 7 doses

Treatment:

Drug: Placebo