Acute Asthma Rescue Therapy Study Part 2

Phase 4

Recruiting

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12605000627651
• Lead Sponsor: Mater Health Services Brisbane Respiratory Medicine Research Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1) Consenting adults. 2) Physician diagnosed asthma AND eithera) have demonstrated a 15% or greater reversibility in FEV1. The reversibility can be historical in the 12 months prior to enrolment; occur spontaneously; or acutely following bronchodilator; or over time following response to bronchodilator and either ICS or OCS.ORb) Show a diurnal variation in PEF of >=20% [(Highest - Lowest)/highest]3) Assessed as requiring ongoing inhaled steroids (ie cannot have trivial or mild asthma)4) Not exhibit ANY of the exclusion criteria.

Exclusion Criteria

1) Mild asthma where exacerbations with PEF less than 80% of best thought to be unlikely during the course of the study.2) Erroneous recording of PEF or falsified entries during the 4 week reliability check. This will be performed using the Vitalograph 2110 Electronic PEF/FEV1 diary. Potential volunteers will be asked to record symptoms and PEF morning and evening for two weeks using the electronic PEF diaries. Hand recorded PEF will be compared to downloaded actual stored PEF to check for reliability and falsified entries. Volunteers with inaccurate or falsified recordings will be excluded from participation. It is understood that this will shift the study from an effectiveness study toward an efficacy study. However, the researchers consider this absolutely essential to ensure valid data collection as up to 22% of volunteers have been shown to falsify entries. Furthermore, studies looking at compliance indicate that the pattern of compliance with PEF tends to become apparent by 2 weeks of recording.3) Asthma requiring continuous OCS or where other agents such as methotrexate, gold or cyclosporin are being trialed.4) No other study drug or trial participation concurrently.NB patients on long acting beta agonists or leukotriene receptor antagonsits will not be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified