Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children - Full Text View

Purpose

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 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:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Montelukast sodium Montelukast

U.S. FDA Resources

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 0.5mg Other Name: Pulmicort Respules
Active Comparator: 2 Montelukast sodium	Drug: Montelukast Sodium 4mg or 5mg Other Name: SINGULAR

Eligibility

Ages Eligible for Study:	2 Years to 8 Years
Genders Eligible for Study:	Both
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

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Bertil Andersson

AstraZeneca

More Information

No publications provided

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:

Asthma
Pulmicort
Children
paediatrics
budesonide

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Montelukast
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013