A study comparing the changes in lung function following the use of salbutamol and symbicort in adults with asthma

Phase 3

Completed

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12619001083189
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-06
• Study Completion: 2020-11-01
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

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
Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnitude of bronchodilation at 180 mins as measured by FEV1[180 minutes post-intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Magnitude of bronchodilation over time as measured by FEV1 using Spirometry[FEV1 at 30 min intervals for 4 hours, then hourly to 8 hours post-intervention commencement];Levels of airway inflammation over time as measured by FeNO[FeNO at 30 min intervals for 4 hours, then hourly to 8 hours post-intervention commencement];Relief of breathlessness as measured by the Modified Borg Score[At 30 minute intervals for 4 hours, then hourly to 8 hours post-intervention commencement];Changes in serum potassium following treatment using blood sampling[At 0, 3 and 8 hours post-intervention commencement];To determine changes in blood eosinophil count following treatment using blood sampling[At 0, 3 and 8 hours post-intervention commencement];Changes in heart rate following treatment using an ECG [At 0, 3 and 8 hours post-intervention commencement];Changes in QTc following treatment using an ECG [At 0, 3 and 8 hours post-intervention commencement]