Asthma is a common, chronic respiratory disease affecting 1–18% of the population in different countries. Asthma is characterized by variable symptoms of wheeze, shortness of breath, chest tightness and/or cough, and by variable expiratory airflow limitation. Both symptoms and airflow limitation characteristically vary over time and in intensity. These variations are often triggered by factors such as exercise, allergen or irritant exposure, change in weather, or viral respiratory infections.
Conditions
Interventions
Trade Name: COMBOTEROL
fluticasone propionate/salmeterol (125µg / 25µg) in MDI HFA inhaler
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: SALMETEROL
CAS Number: 89365-50-4
Current Spo
Sponsors
Lek-Am Sp. z o.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female, age 18-70 2. Asthma diagnosed min 3 months before the screening visit. Therapy minimal requirement - GINA grade 4 3. FEV1 elevation by at least 12% and min. 200 ml after 400 µg of salbutamol application noted at the screening 4. FEV1 50-85% of predicted at the screening visit. 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 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Severe life threatening asthma or hospitalisation due to asthma exacerbation during 3 months before the screening 2. Uncontrolled or untreated significant immunology, endocrinology, hematology, psychiatric, neurology, hepatic, gastrointestinal disorders or neoplasma 3. Heart arythmia or other cardiovascular disorders, including hypertension with DBP = 95 mm Hg 4. Antibiotics taken during last 8 weeks before screening due to respiratory infection 5. Smoking >10 cigarettes/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove non-inferiority in terms of efficacy and safety of new formulation of combination of fluticasone propionate / salmeterol (125µg / 25µg) in MDI HFA inhaler applied two puffs twice daily compared with the reference drug at a dose of 500µg / 50µg in DPI (dry powder inhaler) type disc applied one puff twice daily in patients with chronic asthma. Primary endpoint of the trial: avarage morning PEF during 12-week treatment period (change from Week1 to Week12);Secondary Objective: Additional endpoints are: asthma control assessment with ACT, quality of life assessment (with mAQLQ test), respiratory capacity, salvation drugs usage, adverse events.;Primary end point(s): Primary endpoint of the trial: avarage morning PEF during 12-week treatment period (change from Week1 to Week12);Timepoint(s) of evaluation of this end point: At the last control visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional endpoints are: asthma control assessment with ACT, quality of life assessment (with mAQLQ test), respiratory capacity, salvation drugs usage, adverse events.;Timepoint(s) of evaluation of this end point: Throughout the study till the last control visit | — |
Countries
Poland
Contacts
Public ContactDeputy General Manager
QAH Sp. z o.o. Sp. k.
Outcome results
None listed