New Version Pulmicort Turbuhaler USA Children

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00642161

Collaborator

(none)

430

Enrollment

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2002

Actual Primary Completion Date :

Sep 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Change from Baseline in % predicted Forced Expiratory Volume in 1 second [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 [Week 2, 4 and 8, then at week 12]
Incidence of Adverse Events [Week 2, 4 and 8, then at week 12]
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration [6 or 12 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.