ACTRN12619001083189
Completed
Phase 3
Bronchodilation following repeated administration of budesonide/formoterol vs salbutamol in adult asthma: A randomised, open-label, cross-over study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medical Research Institute of New Zealand
- Enrollment
- 39
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Doctor diagnosis of asthma.
- •Age 16 to 65 years.
- •SABA monotherapy or SABA with regular ICS therapy, or regular ICS/LABA treatment
- •FEV1 40 to 70% predicted as per GLI 2012 criteria
- •Change in FEV1 post 400µg salbutamol via MDI through a spacer \>12% increase from baseline, and \>200ml
Exclusion Criteria
- •Other significant respiratory disorder
- •Other significant cardiovascular disorder such as history of arrhythmia including atrial fibrillation and supraventricular tachycardia
- •Current or recent respiratory tract infection in last 4 weeks
- •Current use of other asthma medications including LAMAs, theophylline, oral corticosteroids, biologics, sodium cromoglycate or nedocromil sodium
- •Asthma exacerbation requiring oral steroids in last 6 weeks
- •Current smoker or smoking history with \>10 pack year history
- •QTCF \> 430ms for men and \> 450ms for women
- •Pregnant, or planning a pregnancy, or breast feeding
- •Allergy to investigational products, including previous adverse effects following administration of similar doses to those used in the study
- •Current use of beta\-blockers
Outcomes
Primary Outcomes
Not specified
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