New Version Pulmicort Turbuhaler USA Adults
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Bertil Andersson, Study Director, Affiliation: AZ employee
Lars-Göran Carlsson, Study Director, Affiliation: AZ employee
Summary
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.
Clinical Details
Official title: 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.
Study design: Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from Baseline in Forced Expiratory Volume in 1 second
Secondary outcome: Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate.Incidence of Adverse Events Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: July 2002
Ending date: January 2005
Last updated: March 18, 2008
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