Effect of cardio selective beta blockers on rescue beta agonists following controlled bronchoconstriction challenge in Asthmatics

Phase 4

Completed

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12618000306213
• Lead Sponsor: Waikato District Health Board, Respiratory Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-01
• Study Completion: 2019-04-09
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Physician diagnosis of asthma
• Airway hyper responsiveness. Demonstrated with post mannitol ( a 15 percent decrease in FEV1 at a cumulative mannitol dose PD15 <635mg/ml)
• Over 18 years of age

Exclusion Criteria

Pre spirometry FEV1 < 60% predicted or < 1.5L
• Dyspnoea at rest
• Past history of hypotension (baseline BP <100/60)
• ECG abnormalities that could interfere with the interpretation of the study:
• HR<60/min
• Symptomatic hypotension
• ECG findings of severe 1st degree, or 2nd & 3rd degree heart block (defined as PR interval > 0.28s)
• LBBB & RBBB are NOT excluded.
• Known adverse reaction to beta blockers or mannitol
• On other drugs that commonly interact with beta blockers (amiodarone, verapramil, cimetidine, digoxin, phenytoin)
• Already taking beta blockers – including eye-drops.
• Smoking history of >10 pack years
• Recent exacerbation as defined by oral corticosteroid use/hospitalisation within 6 weeks of recruitment
• Pregnant (negative pregnancy test required)
• Under 18 year of age
• Unsuitability as defined by the study doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Graph drawn of time against FEV1 measured. Points plotted for 0, 5, 10, 15 minutes (each being after 0, 100micrograms, 100micrograms, 200micrograms salbutamol respectively). Area under curve measured to compare recovery with beta agonist following methacholine challenge. FEV1 will be assessed using hand held spirometry.<br> [This will be measured immediately after methacholine challenge at 0, 5, 10, 15 minutes (each being after 0, 100micrograms, 100micrograms, 200micrograms salbutamol respectively). This challenge will be undertaken at the end of each study arm. ]<br>