Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Chi... https://clinicaltrials.
gov/ct2/show/NCT00641472
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Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children
The safety and scientific validity of this study is the responsibility of the study
sponsor and investigators. Listing a study does not mean it has been evaluated by
the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00641472
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 25, 2009
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
Study Details Tabular View No Results Posted Disclaimer
How to Read a Study Record
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Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Chi... https://clinicaltrials.gov/ct2/show/NCT00641472
Study Description Go to
Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Budesonide inhalation suspension Phase 4
Drug: Montelukast Sodium
Study Design Go to
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 380 participants
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.
Study Start Date : October 2002
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Asthma
Drug Information available for: Budesonide Montelukast sodium
Montelukast
U.S. FDA Resources
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Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Chi... https://clinicaltrials.gov/ct2/show/NCT00641472
Arms and Interventions Go to
Arm Intervention/treatment
Experimental: 1 Drug: Budesonide inhalation suspension
Budesonide inhalation suspension 0.5mg
Other Name: Pulmicort Respules
Active Comparator: 2 Drug: Montelukast Sodium
Montelukast sodium 4mg or 5mg
Other Name: SINGULAR
Outcome Measures Go to
Primary Outcome Measures :
1. Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
[ Time Frame: Each clinic visit ]
Secondary Outcome Measures :
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 ]
Eligibility Criteria Go to
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with
your doctor and family members or friends about deciding to join a study. To
learn more about this study, you or your doctor may contact the study research
staff using the contacts provided below. For general information, Learn About
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Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Chi... https://clinicaltrials.gov/ct2/show/NCT00641472
Clinical Studies.
Ages Eligible for Study: 2 Years to 8 Years (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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 Go to
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study
research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number):
NCT00641472
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bertil Andersson AstraZeneca
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Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Chi... https://clinicaltrials.gov/ct2/show/NCT00641472
More Information Go to
Responsible Party: Lars-Göran Carlsson
ClinicalTrials.gov Identifier: NCT00641472 History of Changes
Other Study ID Numbers: DX-RES-2103
D5257L00750
First Posted: March 24, 2008 Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Asthma
Pulmicort
Children
paediatrics
budesonide
Additional relevant MeSH terms:
Asthma Autonomic Agents
Bronchial Diseases Peripheral Nervous System Agents
Respiratory Tract Diseases Physiological Effects of Drugs
Lung Diseases, Obstructive Anti-Asthmatic Agents
Lung Diseases Respiratory System Agents
Respiratory Hypersensitivity Glucocorticoids
Hypersensitivity, Immediate Hormones
Hypersensitivity Hormones, Hormone Substitutes, and Hormone Antagonists
Immune System Diseases Leukotriene Antagonists
Budesonide Hormone Antagonists
Montelukast Cytochrome P-450 CYP1A2 Inducers
Anti-Inflammatory Agents Cytochrome P-450 Enzyme Inducers
Bronchodilator Agents Molecular Mechanisms of Pharmacological Action
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