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New Version Pulmicort Turbuhaler USA Adults
This study has been completed.
Study NCT00642187   Information provided by AstraZeneca
First Received: March 18, 2008   Last Updated: March 24, 2009   History of Changes

March 18, 2008
March 24, 2009
July 2002
October 2004   (final data collection date for primary outcome measure)
Change from Baseline in Forced Expiratory Volume in 1 second [ Time Frame: Week 2, 4 and 8, then at week 12 ]
Same as current
Complete list of historical versions of study NCT00642187 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
New Version Pulmicort Turbuhaler USA Adults
A Placebo-Controlled Comparison of the Efficacy and Safety of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Adults Currently Treated With Inhaled Steroids.

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

 
Phase III
Interventional
Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
Asthma
  • Drug: budesonide
  • Drug: Placebo
  • Experimental: Pulmicort
  • Placebo Comparator: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
525
October 2004
October 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
  • To enter the run in period, subjects were also required to have the following:
  • A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
  • At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

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 (28 days) 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 the study. Subject must not smoke or have smoked within 6 months of the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00642187
Lars-Göran Carlsson
SD-004-0620, D5254C00620
AstraZeneca
 
Study Director: Bertil Andersson AZ employee
Study Director: Lars-Göran Carlsson AZ employee
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP