Double-blind, double-dummy, multi-center, randomized parallel group trial to demonstrate therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25 µg/125 µg per actuation) versus SeretideTM 125 (25 µg/125 µg per actuation) over a period of 12 weeks in adolescent and adult patients with persistent moderate asthma

Phase 1

• Conditions: persistent moderate asthma; MedDRA version: 9.1Level: LLTClassification code 10003555Term: Asthma bronchial

• Registration Number: EUCTR2007-000134-39-PL
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-10
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 426

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 a 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

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 3 months
17. Desensitization therapy within the last 3 months
18. Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 3 months)
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified