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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000686606
Acronym
CRC P7 S3
Enrollment
100
Registered
2005-10-24
Start date
2005-04-01
Completion date
2006-04-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

This project is to assess the relative effectiveness of two clinically applicable algorithms to guide titration of ICS therapy in subjects with asthma. The effectiveness of the algorithm will be assessed in terms of its capacity to minimise long-term ICS (and oral steroid) usage while maintaining optimal asthma control (asthma-free days and quality of life).Down titration of ICS according to pre-set clinical criteria for well controlled asthma (usual care) or levels of exhaled nitric oxide (eNo)

This project is to assess the relative effectiveness of two clinically applicable algorithms to guide titration of ICS therapy in subjects with asthma. The effectiveness of the algorithm will be assessed in terms of its capacity to minimise long-term ICS (and oral steroid) usage while maintaining optimal asthma control (asthma-free days and quality of life).Down titration of ICS according to pre-set clinical criteria for well controlled asthma (usual care) or levels of exhaled nitric oxide (eNo).

Sponsors

CRC for Asthma
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026