Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-Dose Inhaler (pMDI) or Oxis Turbuhaler - Tabular View

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

March 27, 2009

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Average FEV1 during 12 hours [ Time Frame: Once a week for 5 weeks during treatment period ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00658255 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Urine levels of formoterol in 2 different formulations [ Time Frame: Once a week (12 hour urine collection) for 5 weeks during treatment period ]
Safety profiles of formoterol in 2 different formulations [ Time Frame: Once a week for 5 weeks during treatment period ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-Dose Inhaler (pMDI) or Oxis Turbuhaler

Official Title ^ICMJE

A Randomized, Multicenter, Open-Label, Active-Controlled, Single-Dose, 5-Period, Incomplete Block, Cross-Over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma

Brief Summary

The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Safety Study

Condition ^ICMJE

Stable Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol
Drug: formoterol

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

175

Completion Date

May 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

At least 18 years of age
Diagnosis of asthma and baseline lung function tests as determined by the protocol
Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

Severe asthma
Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Gender

Both

Ages

18 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

NCT00658255

Responsible Party

Study ID Numbers ^ICMJE

SD-039-0729, D5896C00729

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Michael E Ruff, MD	Pharmaceutical Research & Consulting Inc
Study Chair:	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