E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Persistent Asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003561 |
E.1.2 | Term | Asthma, unspecified |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to establish the therapeutic equivalence between the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) and the innovative one (Seretide Diskus®) in terms of their bronchodilator effect in lung function. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are: To establish the superiority of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) over placebo in terms of its bronchodilator effect in lung function. To compare the safety profile of the two Fluticasone/Salmeterol formulations in patients with asthma.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Study subjects are eligible for participation if they meet all of the following criteria:
1. Age 18-65 male or female. 2. Clinical diagnosis of asthma of 6 months prior to screening visit. 3. FEV1 ≥ 50% and ≤ 80% predicted. 4. Airways obstruction reversibility of at least 12% FEV1 (and an absolute increase of at least 0.2 lt) after 400μg of inhaled salbutamol. 5. Stable asthma for at least 4 weeks prior to screening visit. 6. Inhaled steroids (ICS) at a stable dose within the previous 30 days of screening visit and short acting β2-agonists on an "as needed" basis. 7. PIF 30 - 90 lt/min. 8. Patients willing to collaborate at the study visits. 9. Signed and dated written informed consent.
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E.4 | Principal exclusion criteria |
Patients who meet any of the following exclusion criteria are not eligible for enrolment into the study:
1. History of other pulmonary disease, such as COPD, tuberculosis, cystic fibrosis, bronchiectasis. 2. Asthma exacerbation or respiratory infection within the previous 4 weeks. 3. Hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase within the previous 30 days of screening visit. 4. Heavy smokers (>10 cigarettes per day) or any smoking history ≥10 pack years. 5. Change of asthma medication within the previous 4 weeks of screening visit. 6. Seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study period. 7. Unusual responsiveness to sympathomimetic amines. 8. History of ischemic heart disease, severe heart failure, myocardial infarction, tachyarrhythmias, cardiac arrhythmias, third degree atrioventricular block, decompensated heart failure, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe hypertension, prolongation of the QTc>0.44s, aneurysm, convulsive disorders, thyrotoxicosis and pheochromocytoma. 9. Other severe acute or chronic medical or psychiatric condition, which in the opinion of the investigator may increase the risk of patient’s participation or may confound the study results. 10. Pregnancy or lactation. 11. Women of childbearing potential who refuse to use contraception. 12. Allergy to the study medications and their excipients. 13. Any use of a β-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit. 14. Any use of potent CYP3A4 inhibitors, including but not limited to ketoconazole, SSRIs and ritonavir within 2 weeks prior to screening visit. 15. Any use of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) within 2 weeks prior to screening visit. 16. Any use of cromones, MAO inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval within 2 weeks prior to screening visit. 17. Any investigational medication within 12 weeks prior to screening visit. 18. Record of previous non-compliance.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable for the comparison of the two Fluticasone/Salmeterol formulations will be the 12-hour average FEV1 [area under the FEV1 versus time curve divided by 12 (FEV1 AUC0-12/12)]. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |