New Version Pulmicort Turbuhaler USA Adults

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642187
• Other study ID #: SD-004-0620
• Secondary ID: D5254C00620
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2008
• Last updated: January 21, 2011
• Start date: July 2002
• Est. completion date: October 2004

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndonesia: National Food and Drug AgencyPhilippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Forced Expiratory Volume in 1 second		Week 2, 4 and 8, then at week 12
Secondary	Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate.		Week 2, 4 and 8, then at week 12
Secondary	Incidence of Adverse Events		Week 2,4 and 8, then at week 12
Secondary	Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration)		6 or 12 hours post dose