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Lung function measurement to predict the response to changes in the dose of inhaled corticosteroids among asthmatic patients taking combination therapy

Lung function measurement to predict the response to changes in the dose of inhaled corticosteroids among asthmatic patients taking combination therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000039088
Enrollment
60
Registered
2010-01-13
Start date
2009-05-11
Completion date
Unknown
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

Brief summary

The aim of the study is to evaluate the ability of various physiological and inflammatory markers to predict changes in asthma control following changes in the dose of combination therapy. The direction and magnitude of the dose changes are determined for each patient by their baseline level of asthma control. If the baseline variables, either alone or in combination, can predict future benefit or risk from change in treatment then the study will provide new insights into the clinical management of asthma.

Interventions

Measurement of lung function at baseline and at review (spirometry, lung volumes). Measurement of lung biomarkers at baseline and at review (exhaled nitric oxide, multiple breath nitrogen washout, forced oscillation device, sputum induction). Dose adjustment of inhaled corticosteroids based on baseline level of asthma control. The frequency of the medication treatment remains the same for each individual patient as it was prior to entry into the study: If patients are not well-controlled at base

Measurement of lung function at baseline and at review (spirometry, lung volumes). Measurement of lung biomarkers at baseline and at review (exhaled nitric oxide, multiple breath nitrogen washout, forced oscillation device, sputum induction). Dose adjustment of inhaled corticosteroids based on baseline level of asthma control. The frequency of the medication treatment remains the same for each individual patient as it was prior to entry into the study: If patients are not well-controlled at baseline, then the inhaled corticosteroid dose will be doubled over the 8-week period. If patients are well-controlled at baseline, the inhaled corticosteroid dose will be halved in the first 4 weeks and quartered over the subsequent 4 weeks. Patients are reviewed at the end of the 8-week period. If patients remain well-controlled after the initial 8-week period, then patients can stop their inhaled corticosteroid and continue to be monitored over another 8-week period. Patients can return for review if their asthma control worsens at any stage during the study. This is an end-point for the study. In this instance, patients are treated as clinically indicated and will return to the care of their usual treating doctor after the study.

Sponsors

The Woolcock Institute of Medical Research
Lead SponsorOther Collaborative groups

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
17 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Adult Physician-diagnosed asthma Not currently smoking Active asthma requiring preventor medication

Exclusion criteria

Pregnancy Smoking Intubation due to severe asthma exacerbation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026