persistent moderate asthma MedDRA version: 9.1 Level: LLT Classification code 10003555 Term: Asthma bronchial
Conditions
Sponsors
Hexal AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Visit -1: 1. Male or female patients aged 12 to 65 years 2. Written informed consent signed by the patient or for patients younger than 18 years (adolescents) signed by the parent(s) or by the legal guardian prior to any protocol specific procedures 3. Medical history of moderate persistent asthma (according to GINA) of at least 6 months duration 4. Regular use of ICS or ICS plus LABA over the 6 months immediately prior to Visit -1 5. Regular treatment with high-dose ICS or low- to medium-dose ICS plus LABA within the 4 weeks immediately prior to Visit -1 6. FEV1 greater than 60% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for rapid-acting beta2-agonists (RABA) and at least 12 hours for LABA 7. Reversible and variable airflow limitation: At least 15% increase of FEV1 15-20 min after RABA inhalation (400 µg salbutamol) 8. Ability to read and write and to fill in the patient diary 9. Ability to handle correctly the metered-dose inhalers and the peak flow meter At visit 0: 1. FEV1 greater than 60% and less than 80% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for RABA (reliever medication) 2. FEV1 within +/- 15% of the value obtained at V-1 3. At least 2 of the following criteria fulfilled during the last 7 days of the run-in period: 3.1. Nighttime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 1 day 3.2. Daytime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 3 days 3.3. Use of RABA on at least 4 days Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Visit -1: 1. Intermittent or persistent mild or severe asthma as defined by GINA 2. Evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis, chronic obstructive pulmonary disease 3. Respiratory tract infection (including sinusitis) within 4 weeks prior to Visit -1 4. Acute asthma exacerbation within 4 weeks preceding Visit -1 5. Acute asthma exacerbation requiring hospitalization or emergency room visit within 12 weeks preceding Visit -1 6. History of life-threatening acute attacks or intubation for asthma 7. History of seasonal asthma exacerbation 8. History of paradoxical bronchospasm after inhaled asthma therapy 9. Active or inactive lung tuberculosis 10. Smoking habits: current smokers or previous smokers who stopped smoking less than 6 months before Visit -1. 11. Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with moderate persistent asthma 12. Patients naive for inhaled corticosteroids 13. Change in asthma medication or regimen (other than inhalation of RABA) within 4 weeks preceding Visit -1 14. Administration of cromones within 4 weeks preceding Visit -1 15. Administration of oral corticosteroids within 4 weeks preceding Visit -1 16. More than 2 courses of oral corticosteroids within the last 12 weeks 17. Allergen-specific immunotherapy within the last 12 weeks 18. Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 12 weeks) 19. Use of beta-blockers, non-potassium sparing diuretics or potent inhibitors of the cytochrome P450-3A4 system like ketoconazole, itraconazole, ritonavir within 4 weeks preceding Visit -1 20. Vaccination with live-attenuated virus within 2 weeks preceding Visit -1 21. Impaired adrenal cortex function 22. Severe renal or hepatic disease 23. Hypokalemia uncorrected and/or serum potassium value on Visit -1 less than 3.5 mmol/L 24. Acute or history of severe cardiovascular disorders (New York Heart Association class II-IV heart failure, heart rhythm abnormalities) 25. Untreated or unstable hypertension 26. Known diabetes of all types 27. Hyperthyroidism not adequately controlled 28. Glaucoma 29. History of hypersensitivity to one or both of the active ingredients or to any other component of the preparations or reliever medication 30. Presence of any other severe decompensated concomitant disease (endocrine, hematological, neurological, immunological) 31. Known abnormal chest radiography 32. Other relevant 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. At Visit 0: 1. Acute respiratory tract infection during run-in period 2. Severe asthma exacerbation during run-in period 3. Any intake of asthma medication other than the inhalation of the supplied reliever medication during run-in period 4. Use of more than 12 actuations of reliever medication on any single day during the run-in period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): FEV1 at the end of the 12-week study period (Visit 4) compared with baseline (Visit 0). ;Main Objective: The primary aim of this study is to show therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25µg/125µg per actuation) to Seretide TM 125 (25µg/125µg per actuation, Glaxo Wellcome UK Ltd., United Kingdom). Equivalence respectively non-inferiority will be concluded if the resulting 97,5% confidence interval for the difference between the two treatment groups with respect to the change in FEV1 (Visit 4 minus Visit 0) is completely contained within the acceptance range [-200 ml; 8].;Secondary Objective: Efficacy: Change in FEV1 from baseline to Visit 2; Development of FEV1, FEV1 % predicted and FVC over the course of the study; Change in morning pre-dose PEF from baseline period; Development of the weekly morning and evening PEF over the course of the study, Change in daytime and nighttime symptoms score over time; Frequency of use of reliever medication; Incidence and severity of asthma exacerbations, Number of patients discontinuing the study due to asthma worsening, Overall assessment of efficacy by patient and investigator Safety: Incidence and severity of AEs and drug-related AEs; Morning serum cortisol levels at Visit 4 (or last study visit for patients withdrawn); Clinically relevant changes in laboratory parameters, vital signs, ECG and physical examination parameters from Visit -1 to Visit 4; Incidence of patients with oral candidiasis or voice hoarseness; Overall assessment of tolerability of the investigational product by patient and investigator | — |
Countries
Hungary, Lithuania
Outcome results
None listed