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Randomised placebo controlled trial of inhaled corticosteroids for treatment of chronic cough in children.

Is a two week course of inhaled corticosteroids efficacious for reducing cough severity in children with chronic cough, compared to placebo?

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001713482
Enrollment
77
Registered
2016-12-14
Start date
2011-06-07
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

This study will help us answer the question: should children with chronic cough be given inhaled corticosteroids to promote faster recovery and improve ability for children to return to their normal daily routines? This study will also evaluate whether fractional exhaled nitric oxide levels can predict short term response to inhaled corticosteroids in children with chronic cough. We hypothesise that a short (two week) course of inhaled corticosteroids will reduce cough severity in children with chronic cough, and that FeNO measurements can be used to predict this response.

Interventions

Children will be randomised to receive either inhaled corticosteroids or placebo. Children allocated to the intervention group will receive 250 micrograms fluticasone propionate twice daily for two weeks, delivered via metered dose inhaler and spacer (with or without mask, depending on age and technique).

Sponsors

Prof Anne Chang
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
18 Months to 16 Years
Healthy volunteers
No

Inclusion criteria

Children with chronic cough. Chronic cough is defined as cough duration of >=4 weeks.

Exclusion criteria

Children who have received oral or inhaled corticosteroids in the week prior to presentation. Children who are unable to tolerate inhaled corticosteroids or adequately use spacer. Children with cerebral palsy or severe neuro-developmental abnormality. Children with physician-confirmed underlying chronic respiratory illness. Children who are immunocompromised.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026