Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 18, 2008
Last updated: March 24, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Drug: Budesonide inhalation suspension
Drug: Montelukast Sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids [ Time Frame: Each clinic visit ]

Secondary Outcome Measures:
  • Incidence and Severity of Adverse Events [ Time Frame: Each clinic visit ]
  • Time to 1st additional asthma medication measured at 12 weeks and 26 weeks [ Time Frame: Each clinic visit ]
  • 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 ]

Estimated Enrollment: 380
Study Start Date: October 2002
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Budesonide inhalation suspension
Drug: Budesonide inhalation suspension
Other Name: Pulmicort Respules
Active Comparator: 2
Montelukast sodium
Drug: Montelukast Sodium
4mg or 5mg
Other Name: SINGULAR


Ages Eligible for Study:   2 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00641472

Sponsors and Collaborators
Study Director: Bertil Andersson AstraZeneca
  More Information

Responsible Party: Lars-Göran Carlsson
ClinicalTrials.gov Identifier: NCT00641472     History of Changes
Other Study ID Numbers: DX-RES-2103  D5257L00750 
Study First Received: March 18, 2008
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016