New Version Pulmicort Turbuhaler USA 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. Identifier: NCT00642161
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : January 24, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: budesonide Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : November 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

Intervention Details:
    Drug: budesonide
    Other Name: Pulmicort

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Incidence of Adverse Events [ Time Frame: Week 2, 4 and 8, then at week 12 ]
  3. Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration [ Time Frame: 6 or 12 hours post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT00642161

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

Responsible Party: Lars-Göran Carlsson Identifier: NCT00642161     History of Changes
Other Study ID Numbers: SD-004-0726
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
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