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Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

This study has been completed.
Information provided by:
AstraZeneca 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
Asthma Drug: Budesonide inhalation suspension Drug: Montelukast Sodium Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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   (Child)
Sexes Eligible for Study:   All
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 identifier: NCT00641472

Sponsors and Collaborators
Study Director: Bertil Andersson AstraZeneca
  More Information

Responsible Party: Lars-Göran Carlsson Identifier: NCT00641472     History of Changes
Other Study ID Numbers: DX-RES-2103
Study First Received: March 18, 2008
Last Updated: March 24, 2009

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017