Titratable Dosing in Moderate to Severe Asthmatics - Tabular View

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

March 27, 2009

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. [ Time Frame: 7 assessments within 12 month treatment period ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00651768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To measure changes in lung function tests, patient reported outcomes and usage of medical resource [ Time Frame: 7 assessments within 12 month treatment period ]
Blood levels of budesonide and formoterol [ Time Frame: 10 blood samples taken at 1 visit in a sub-set of patients ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Titratable Dosing in Moderate to Severe Asthmatics

Official Title ^ICMJE

A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma

Brief Summary

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol
Drug: Symbicort pMDI + budesonide HFA pMDI

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

570

Completion Date

January 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00651768

Responsible Party

Study ID Numbers ^ICMJE

SD-039-0728, D5896C00728

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Catherine Bonuccelli

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

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