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OpenTrials
Completed

NCT Number: NCT00641472

Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 2 to 8 at study entry
  • At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
  • use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in

Exclusion criteria

  • Severe or unstable asthma
  • any significant finding at a physical exam
  • an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor

Treatment and study plan

Budesonide inhalation suspension

Drug

0.5mg

Other names: Pulmicort Respules

montelukast sodium

Drug

4mg or 5mg

Other names: SINGULAR

Primary outcomes

  1. Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids

    Time frame: Each clinic visit

Secondary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: Each clinic visit

  2. Time to 1st additional asthma medication measured at 12 weeks and 26 weeks

    Time frame: Each clinic visit

  3. Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks

    Time frame: Each clinic visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Mar 24, 2008
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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