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Status:

COMPLETED

RCT of a Written Action Plan vs. Usual Care in Children With Acute Asthma

Lead Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsors:

Fonds de la Recherche en Santé du Québec

Conditions:

Asthma

Eligibility:

All Genders

1-17 years

Phase:

PHASE4

Brief Summary

The objective of the proposed large, high-intensity, randomised controlled trial is to evaluate the real-life effectiveness of providing a written action plan to asthmatic children discharged from the...

Detailed Description

The objective of the proposed large, high-intensity, randomised controlled trial is to evaluate the real-life effectiveness of providing a written action plan to asthmatic children discharged from the...

Eligibility Criteria

Inclusion

  • Children will be eligible, whether they are discharged from the ED or following a hospital admission, if:
  • aged 1 to 17 years;
  • presenting with acute asthma as per the 2003 Canadian Consensus Statement - The ED physician will be responsible for confirming the diagnosis of asthma;
  • requiring at least one nebulisation of salbutamol;
  • the ED physician plans on prescribing the patient inhaled steroids and/or inhaled b2-agonists delivered by metered dose inhaler or continuing a previously prescribed inhaled steroid;
  • the patient intends to stay in the Province of Quebec in the next 45 days;
  • the patient (and their parents) have a good understanding of written and spoken French or English.

Exclusion

  • Children will be excluded if they:
  • currently take asthma medications (ß2-agonist and/or inhaled steroids) using a turbuhaler or diskus, because these delivery devices cannot be fitted with Doser CT, a computerized electronic dose counter for metered dose inhalers;
  • have another chronic lung disease (other than asthma) such as cystic fibrosis or bronchopulmonary dysplasia;
  • have known hypersensitivity to inhaled salbutamol or fluticasone.

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

218 Patients enrolled

Trial Details

Trial ID

NCT00381355

Start Date

October 1 2006

Last Update

March 27 2014

Active Locations (1)

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1

Ste-Justine Hospital

Montreal, Quebec, Canada, H3T 1C5