Small particle steroid study

Small particle steroid study: a randomized double blind double dummy study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17195095

Enrollment

Registered

2013-01-07

Start date

2009-09-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Asthma / Small airways Respiratory Asthma

Interventions

After a 3-week run-in on DPI-BUD patients are randomized to either arm 1 (DPI- BUD switched to BDP-HFA from wk 4 to wk 15) or to arm 2 (remaining on DPI-BUD) The intervention takes 15 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Well-established, stable asthma patients on inhaled corticosteroids 2. Age >18 years, male/female 3. Elevated baseline Sacin (>0.12 L-1)

Exclusion criteria

Exclusion criteria: 1. Smoking history (> 10 packyears) or current smokers 2. Pregnant women

Design outcomes

Primary

Measure	Time frame
Change in Sacin (Multiple Breath Nitrogen Washout test). Sacin is a measure of ventilation heterogeneity in the acinar lung zone. Sacin increases with increasing heterogeneity. Measured at baseline and after 3, 9 and 15 weeks.	—

Secondary

Measure	Time frame
1. Alveolar and bronchial exhaled NO 2. Lung function parameters 3. Asthma control test (ACT) score Measured at baseline and after 3, 9 and 15 weeks.	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026