E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diagnosis of moderate to severe persistent asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
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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 is to compare the therapeutic efficacy, in non-interiority model, of 12 weeks of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25µg, taken BID, versus SERETIDE®DISKUS® 500µg BID taken by inhalation, in patients with moderate to severe persistent asthma. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is: 1.to evaluate the safety of a 24 weeks course of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25µg BID, taken by inhalation, in patients with moderate to severe asthma 2. to compare the safety of SMB BUDESONIDE-SALMETEROL DPI CAPSULE 300/25µg BID taken by inhalation versus SERETIDE®DISKUS® 500µg BID taken by inhalation, in patients with moderate to severe persistent asthma over 12 weeks. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Male or female, aged between 18 and 70 years of age inclusive; 2) History of moderate to severe persistent asthma for at least 3 months prior to the screening visit; 3) Reversibility of at least 12% in FEV1 , following inhalation of 400 μg salbutamol at screening and baseline; 4) FEV1 (in each of three consecutive measures) more than or equal to 50% (upper limit 80%) of predicted at screening and baseline (prior to dosing with study medication); 5) Able to comply with all study procedures, including the use of study inhalers, spirometer and peak flow meter; 6) Willing to withhold the use of short acting beta-agonists for at least 6 hours prior to each clinic visit; 7) Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form; 8) If the patient is female and of childbearing potential, she must be using an efficient means of birth control, as determined by the investigator and provide a negative blood and urine pregnancy test at the screening visit and a negative urine dipstick pregnancy test at the randomisation visit. |
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E.4 | Principal exclusion criteria |
1) Severe life-threatening asthma or hospitalisation for an asthma exacerbation within 3 months prior to the screening visit and hospitalisation for a related disorder (pneumothorax, bronchopneumonia, etc.) in the past 3 months before screening visit; 2) Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease; 3) Presence or history of any significant cardiac arrhythmia or diagnosed cardiac disease including coronary artery disease, congestive heart failure and uncontrolled hypertension (defined as having a diastolic blood pressure of 95 mmHg or above or a systolic blood pressure of 140 mmHg or above); 4) Respiratory tract infection requiring treatment with antibiotics within 8 weeks prior to the screening visit; 5) Any significant respiratory disorder other than asthma; 6) Smokers of more than 10 cigarettes/day (or equivalent) or a smoking history of more than 10 pack years; 7) Pure seasonal asthma and/or a history of seasonal exacerbation of asthma; 8) Use of any of the prohibited medication as detailed in the concomitant medication section; 9) Participation in any other clinical trial within 3 months of the screening visit; 10) Participation in any other clinical trial with SMB BUDESONIDE-SALMETEROL DPI; 11) Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study; 12) Patients with any sensitivity or allergy to any of the products used within this clinical trial; 13) Patients with diabetes mellitus; 14) History of drug and/or alcohol abuse. 15) Incompliance to PEF tests and study medication (more than 20% of PEF tests or study medication intake missing) during the run-in period; 16) Patients who received oral or parenteral steroids in the preceding 8 weeks. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change over the week 0 to 12 in morning PEF is the primary end-point of the study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |