Bronchial Asthma
Conditions
Interventions
Trade Name: Pulmoton/Elpenhaler (200/6)mcg
Product Name: Pulmoton/Elpenhaler
Pharmaceutical Form: Inhalation powder
Trade Name: Symbicort Turbuhaler
Product Name: Symbicort Turbuhaler
Pharmaceutical
Sponsors
ELPEN Pharmaceutical Co. Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria. 1) Eligible ages for the study: 18-65 years 2) Eligible for studying gender: Men and Women 3) Non smokers 4) History compatible with asthma and clinical diagnosis of asthma 5) Improvement in FEV1> 12% and> 200ml in spirometry in bronchodilation test 6) FeNO> 30ppb 7) Patients who have fully understand the study protocol and signed the consent form 8) Patients with asthma, who are not treated with ICS or montelukast for the last three months prior to entering the study 9) Patients who are not treated corticosteroids for the last three months prior to entering the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 ) Patients with hypersensitivity to budesonide, formoterol or lactose 2 ) Patients , regardless of gender , age <18 years 3 ) Patients with asthma,treated with montelukast or ICS for the last three months prior entering the study 4 ) Patients being treated with corticosteroids fot the last three months prior entering the study 5) Patients treated with potent CYP3A4 inhibitor 6 ) Patients with severe cardiovascular disease or prolongation of QTc 7) Patients with untreated hypokalaemia 8) Patients with severe liver cirrhosis 9) Patients with thyrotoxicosis , pheochromocytoma or diabetes 10) Patients with other lung disease ( COPD, bronchiectasis , allergic rhinitis without treatment , etc . ) 11) Patients during asthma exacerbation 12) Female patients who are pregnant , breastfeeding or planning to become pregnant 13) Patients with known existing tumor or autoimmune disease known 14) Patients with known psychiatric illness, or other condition which interferes with patient compliance to the procedures of the study 15) Patients with respiratory infection the last 8 weeks 16) Patients with severe asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is the evaluation of the effect of inhaled combination of budesonide - formoterol (Pulmoton® Elpenhaler®) in exhaled nitric oxide (FeNO) of patients with bronchial asthma.;Secondary Objective: Secondary objectives : - Comparison of the effect of Pulmoton® Elpenhaler® in FeNO, in patients with asthma, with the reference product Symbicort® Turbuhaler®. - Investigation of correlation between the existence of improvement ( reduction ) of FeNO with spirometry and the score of ACT questionnaire, by treatment group . - Collection of demographic data and safety .;Primary end point(s): The change in the mean value of the exhaled nitric oxide (FeNO) between visits.The price will be expressed in parts per Billiard (ppb). All study sites will use the same type of analyzer NIOX® MINO and the recommendations of ATS for measuring FeNO,will be taken into consideration in order to exclude variations in the measurements.;Timepoint(s) of evaluation of this end point: baseline,4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary variables of this study are: - The score of the ACT questionnaire , and - The FEV1 value recorded during the spirometry test.;Timepoint(s) of evaluation of this end point: Between visits | — |
Countries
Greece
Contacts
Public ContactKaterina Vidanopoulou
ELPEN Pharmaceutical Co. Inc.
Outcome results
None listed