asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: ComboFS 250 mcg/25 mcg
Pharmaceutical Form: Capsule
INN or Proposed INN: Fluticasone propionate
CAS Number: 80474-14-2
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
PRZEDSIEBIORSTWO FARMACEUTYCZNE LEK-AM SPÓLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 years and older 2. Patient/Subject or legal representative has signed the ICF prior to any protocol specific procedure 3. Symptomatic patients suffering from unstable asthma partly controlled according to international recommendations provided by GINA 2019: a. with 60% =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease specific criteria 1. Acute upper respiratory infection within 4 weeks prior to Visit 2 (Baseline)or during screening/run-in period. 2. Acute lower respiratory infection within 12 weeks prior to Visit 2 (Baseline) or during screening/run-in period. 3. Unstable asthma as evidenced by a. any deterioration of asthma / acute asthma exacerbation requiring hospitalization or emergency room visit or b. any change in asthma therapy (other than inhalation of short-acting ß2 agonists) within 6 months preceding Visit 2 (Baseline) 4. Previous history of life-threatening acute attacks or intubation for asthma 5. History of seasonal asthma exacerbation, 6. Active or inactive lung tuberculosis or evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis, COPD, 7. Smoking within 6 months prior to visit 2 or during the study; for ex-smokers a smoking history of more than 10 pack-years (the equivalent of one pack per day for 10 years) Previous / Concomitant medication 8. Patients naive for inhaled corticosteroids 9. More than 4 short courses of oral corticosteroids within the last year before visit 2 or any oral steroids within 6 months prior to visit 2. 10. Allergen immunotherapy in escalation dose regime within 3 months preceding visit 2 11. Within 3 days preceding to visit 1 or planned to be applied during the trial (after Visit2) use of: a. leukotriene antagonists, inhaled cromolyn sodium; oral or parenteral corticosteroids (oral steroids are permitted for one period of maximal 14 days during the trial), long acting ß2-agonists (other than study medication), theophylline, inhaled anti-cholinergics, b. ß-blockers or potent inhibitors of the cytochrome P450-3A4 system e.g. ketoconazole, itroconazole (Selective ß-blockers i.e. Nebivolol or Bisoprolol can be taken), c. Vaccination with live-attenuated virus; exception: oral polio vaccine (Sabin) is allowed 12. Use of short-acting ß2 agonists within 6 hours preceding Visit 2 or planned to be applied during the trial except to rescue medication; Other diseases and conditions 13. Impairment of adrenal cortex function, severe renal or hepatic disease. 14. Acute or history of severe cardiovascular disorders including cardiac arrhythmia, tachycardia (more than 120), idiopathic subvalvular coarctation of the aorta. 15. Serum potassium value on screening visit ? 3,5 mmol/L 16. Not controlled diabetes mellitus. 17. Not controlled hyperthyroidism. 18. History of paradoxical bronchospasm after inhalative asthma therapy. 19. History of hypersensibility to one or both of the active ingredient or to any other component of the IMP,Seretide® Diskus®, or rescue medication. 20. Presence of any other severe decompensated concomitant systemic disease (cardiovascular, endocrine, hematological, neurological, immunological) as judged by the investigator. 21. Other significant medical condition, ECG abnormality or laboratory profile that might compromise the patient’s safety, compliance, or interfere with the evaluation or preclude completion as judged by the investigator or other contraindication to test drug Special restrictions for females 22. Pregnant or nursing women 23. Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized / hysterectomized or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate equivalence of the test IMP, ComboFS 250 mcg/25 mcg and 125 mcg/25 mcg of fluticasone propionate and salmeterol to the reference IMP, Seretide® Diskus® 500 mcg/50 mcg and 250 mcg/50 mcg of fluticasone propionate and salmeterol, regarding the change from baseline in forced expiratory volume in 1 second (FEV1) at day 56 and day 112 as well as baseline adjusted area under the serial FEV1 from 0 to 12 hours (AUC0-12 hours) on the first day of treatment. Primary objective will be assessed in the first 40 subjects enrolled, while primary objective of the study for the change from baseline in FEV1 at the end of each 8-week treatment period will be assessed in other patients enrolled. The limitation of the size of population is motivated by technical difficulties in performing serial spirometry in COVID pandemic, while the size of the subpopulation under this analysis should be sufficient to provide required testing power. ;Secondary Objective: The secondary objectives will include the evaluation of the change from baseline in forced expiratory volume in 1 second (FEV1) at day 56 and day 112 as well as changes in morning peak expiratory flow (PEF) rate, analysis of FEV1 measurements performed on each visit, as well as the assessment of Asthma Control Questionnaire results. Moreover, safety of the IMPs, in particular changes in morning serum and serial blood collection samples cortisol levels will be evaluated. Secondary objective of the study for baseline adjusted under the serial FEV1 from time 0 to 12 hours (AUC0-12 hours) at the end of each study period and serial serum cortisol levels will be assessed in the first 40 subjects enrolled to the study, while other secondary objectives of the study will be assessed in the relevant population from the whole group of subjects enrolled to the study. Safety parameters will include, among others, the assessment of serum potassium levels and results of ECG examinations.;Primary end point(s): To demon | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives will include the evaluation of baseline adjusted FEV1 AUC 0-12 hours at the end of each study periods, which will be evaluated on day 56, and day 112, as well as the evaluation of changes in morning peak expiratory flow (PEF) rate, analysis of FEV1 measurements performed each visit, as well as the assessment of Asthma Control Questionnaire (ACQ) results. Moreover, safety of the IMPs, in particular changes in morning serum and serial blood collection samples cortisol levels will be evaluated. Secondary endpoint of the study for baseline adjusted under the serial FEV1 from time 0 to 12 hours (AUC0-12 hours) at the end of each study period and serial serum cortisol levels will be assessed in the relevant subpopulation of the first 40 subjects enrolled to the study, while other secondary endpoints will be assessed in the relevant population from the whole group of subjects enrolled to the study. Safety The following safety parameters will be assessed: 1. Safety laboratory examination: haematology, clinical chemistry (serum potassium levels in particular) and cortisol levels; 2. Vital signs (blood pressure, heart rate, body temperature); 3. Results of ECG examination; 4. Results of physical examination; 5. Adverse events. ;Timepoint(s) of evaluation of this end point: Day 0, 14,4 2, 56, 70, 98, 112. | — |
Countries
Poland
Contacts
Public ContactAgata Lazarowicz
Clinscience Sp. z o.o.
Outcome results
None listed