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

This study has been completed.

First Received on April 1, 2008. Last Updated on January 21, 2011 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00658255

Purpose

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.

Condition	Intervention	Phase
Stable Asthma	Drug: budesonide/formoterol Drug: formoterol	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	175
Study Start Date:	October 2002
Study Completion Date:	May 2003

Arms	Assigned Interventions
Experimental: 1	Drug: budesonide/formoterol Other Name: Symbicort
Active Comparator: 2	Drug: formoterol Other Name: Oxis Turbuhaler

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658255

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00658255 History of Changes
Other Study ID Numbers:	SD-039-0729, D5896C00729
Study First Received:	April 1, 2008
Last Updated:	January 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

stable asthma
adults
formoterol

Symbicort
Oxis Turbuhaler
bronchodilation

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012