New Version Pulmicort Turbuhaler USA Children

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 18, 2008
Last updated: January 21, 2011
Last verified: January 2011
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

Condition Intervention Phase
Drug: budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Placebo-controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from Baseline in % predicted Forced Expiratory Volume in 1 second [ Time Frame: Week 2, 4 and 8, then at week 12 ]

Secondary Outcome Measures:
  • Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate [ Time Frame: Week 2, 4 and 8, then at week 12 ]
  • Incidence of Adverse Events [ Time Frame: Week 2, 4 and 8, then at week 12 ]
  • Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration [ Time Frame: 6 or 12 hours post dose ]

Estimated Enrollment: 430
Study Start Date: November 2002
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: budesonide
    Other Name: Pulmicort

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
  • A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
  • Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.

Exclusion Criteria:

  • Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
  • Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
  • Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00642161

Sponsors and Collaborators
Study Director: Bertil Andersson AstraZeneca employee
Study Director: Lars-Göran Carlsson AstraZeneca employee
  More Information

Responsible Party: Lars-Göran Carlsson Identifier: NCT00642161     History of Changes
Other Study ID Numbers: SD-004-0726  D5254C00726 
Study First Received: March 18, 2008
Last Updated: January 21, 2011
Health Authority: Indonesia: National Food and Drug Agency
Philippines: Bureau of Food and Drugs
Singapore: Health Sciences Authority
Thailand: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 26, 2016