RecruitingPhase 4ACTRN12616001713482

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?


Sponsor

Prof Anne Chang

Enrollment

77 participants

Start Date

Jun 7, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 MonthssMax Age: 16 Yearss

Inclusion Criteria1

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

Exclusion Criteria5

  • 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.

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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 we

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).


Locations(2)

Lady Cilento Children's Hospital - South Brisbane

NT,QLD, Australia

Royal Darwin Hospital - Tiwi

NT,QLD, Australia

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ACTRN12616001713482