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Clinical Trials/EUCTR2005-004115-29-DE
EUCTR2005-004115-29-DE
Active, not recruiting
Not Applicable

Investigation to identify predictors of response to a treatment with montelukast

Research Institute for the prevention of allergy and airway diseases in childhood0 sitesSeptember 8, 2005
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DrugsSINGULAIR junior° 5 mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Research Institute for the prevention of allergy and airway diseases in childhood
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 8, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Research Institute for the prevention of allergy and airway diseases in childhood

Eligibility Criteria

Inclusion Criteria

  • •·Children and adolescents with symptomatic bronchial asthma despite ongoing therapy
  • •·Age 6\-14 years
  • •·Asthma diagnosed at lease six months previously (by a special pulmonary allergologic outpatient unit)
  • •·Demonstration of reversibility (FEV1 increased by at least 12% after bronchospasmolysis with a beta2 sympathomimetic). This can be determined at the screening visit or within the previous three months.
  • •·Patients who are either steroid\-naive or who received constant doses of the following medications within the previous four weeks:
  • •\-Beclomethasone dipropionate: up to 400 µg daily
  • •\-Fluticasone propionate: up to 200 µg daily
  • •\-Budesonide: up to 400 µg daily
  • •·Patients who are able to reliably complete the asthma diary and perform peak flow measurements according to instructions.
  • •Are the trial subjects under 18? yes

Exclusion Criteria

  • •·Patients who were treated with systemic steroids within the previous 30 days
  • •·Patients using one of the following asthma medications:
  • •Systemic steroids
  • •Nedocromil, DNCG
  • •Theophylline
  • •Systemic or long\-acting beta2 sympathomimetics
  • •·Patients who have experienced one of the following events within the previous 30 days:
  • •A change in asthma medication
  • •Pulmonary infection
  • •Hospitalization due to bronchial asthma or any other respiratory condition

Outcomes

Primary Outcomes

Not specified

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