A randomised, controlled trial of two different algorithms for maintaining asthma control during down titration on long acting bronchodilators and inhaled corticosteroids (CRC P7S3)

Phase 4

Completed

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12605000686606
• Lead Sponsor: CRC for Asthma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Asthma must be well controlled over the two weeks prior to entry on ICS > 100 mcgs fluticasone or equivalent daily + LABA (salmeterol or formoterol), with medication dose stable for four weeks prior to entry. a.FEV1 criterion for well controlled asthma at entry: FEV1 must be within 10% of the best within the last 2 years, and equal to or above 65% of predicted FEV1 b.Maximum reliever use must be 3 times weekly (excluding prophylactic use for exercise) at Visit 1.

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma free days[Participants will visit the clinic to be evaluted every 2 months for 8 months.];Quality of life[Participants will visit the clinic to be evaluted every 2 months for 8 months.]

Secondary Outcome Measures

Name	Time	Method
Total exacerbations[Over 8 months];Mean steroid dose (oral and inhaled)[Measured every 2 months for 8 months.];Asthma control questionnaire score[Measured every 2 months for 8 months.];Clinic FEV1[Measured every 2 months for 8 months.];Mean morning PEF[2 weeks before and after dose changes];AHR[Measured every 2 months for 8 months.];eNo[Measured every 2 months for 8 months.];Symptom score[Measured every 2 months for 8 months.];Reliever use.[Measured every 2 months for 8 months.]