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Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics (KINECO)

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00964535
First received: August 24, 2009
Last updated: February 12, 2010
Last verified: February 2010
History of Changes
  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 1
Phase 2

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
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 May 23, 2013