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

Orion Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Asthma

Treatments: Drug: budesonide and formoterol 200/6 microg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964535

3103002

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

87 participants in 4 patient groups

Budesonide/formoterol Easyhaler

Experimental group

Treatment:

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Charcoal and Budesonide/formoterol EH

Experimental group

Treatment:

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Symbicort Turbohaler

Active Comparator group

Treatment:

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Charcoal and Symbicort Turbohaler

Active Comparator group

Treatment:

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg

Drug: budesonide and formoterol 200/6 microg