Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics - Full Text View

Sponsor:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00964535

Purpose

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

Condition	Intervention	Phase
Asthma	Drug: budesonide and formoterol 200/6 microg	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Charcoal Formoterol fumarate Budesonide Charcoal, activated Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations [ Time Frame: within 24 h ] [ Designated as safety issue: No ]

Enrollment:	87
Study Start Date:	September 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Budesonide/formoterol Easyhaler	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose Other Name: Budesonide/formoterol Easyhaler 200/6 microg/inhalation
Experimental: Charcoal and Budesonide/formoterol EH	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose with the concurrent charcoal blockage Other Name: Budesonide/formoterol Easyhaler 200/6 microg/inhalation
Active Comparator: Symbicort Turbohaler	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose Other Name: Symbicort Turbohaler 200/6 microg/inhalation
Active Comparator: Charcoal and Symbicort Turbohaler	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose with the concurrent charcoal blockage Other Name: Symbicort Turbohaler 200/6 microg/inhalation

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females aged 18-60 years with documented diagnosis of asthma
Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
The asthma should be stable on the same regular treatment for at least 4 weeks before screening.

Exclusion Criteria:

Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
Respiratory infection within 4 weeks preceding the screening
Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964535

Locations

United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Study Director:

Ulla Sairanen, MSc

Orion Corporation, Orion Pharma

More Information

No publications provided

Responsible Party:	Ulla Sairanen, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00964535 History of Changes
Other Study ID Numbers:	3103002
Study First Received:	August 24, 2009
Last Updated:	February 12, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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