E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
To demonstrate the non-inferiority in terms of acute bronchodilator effect (FEV1 AUC0-12h) between a single dose of CHF 1535 NEXThaler® 200 + 6 µg and a single dose of CHF 1535 NEXThaler® 100 + 6 µg at two dose levels (4 and 1 inhalations) in partially controlled and uncontrolled adult asthmatic patients. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the efficacy of the two strengths on pulmonary function in terms of FVC (peak and AUC0-12h) and FEV1 other parameters (peak, AUC0-4h and AUC4-12h);
• To evaluate the safety profile in terms of adverse events (AEs) and adverse drug reactions (ADRs). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient's written informed consent obtained prior to any study-related
procedures.
2. Male or female aged between 18 and 65 years inclusive;
3. Evidence for "partially controlled" or "uncontrolled" asthma;
4. Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
5. FEV1 between 60% and 85% of the predicted normal values;
6. A documented positive response to the reversibility test;
7. Non-smokers or ex-smokers;
8. A cooperative attitude and ability to be trained in the proper use of a
DPI.
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
2. Significant seasonal variation in asthma occurring or expected to occur during study
participation;
3. History of near fatal asthma, brittle asthma, accident and emergency
treatment or hospitalisation for asthma exacerbation in Intensive Care
Unit within 1 year before screening;
4. Occurrence of asthma exacerbations or respiratory tract infections in
the 4 weeks preceding the screening;
5. Diagnosis of Chronic Obstructive Pulmonary Disease;
6. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin
deficiency;
7. Diagnosis of restrictive lung disease;
8. Patients treated with oral or parenteral corticosteroids in the previous
8 weeks;
9. Intolerance or contra-indication to treatment with beta2-agonists
and/or inhaled corticosteroids;
10. Allergy, sensitivity or intolerance to study drugs or excipients;
11. Patients who received any investigational drug within the last 8
weeks before the screening;
12. Patients taking any of the non-permitted concomitant medication;
13. Subjects unlikely to comply with the study protocol;
14. Any clinically relevant abnormal value or physical finding at screening;
15. Significant medical history;
16. Abnormal and clinically significant 12-lead electrocardiogram;
17. Patients with low compliance of QVAR intake. |
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E.5 End points |
E.5.1 | Primary end point(s) |
FEV1 area under the curve (AUC) over 12 hours post dose standardised by time (AUC0-12h, L) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
FEV1 taken at pre-dose within 60 min of the dose and at 10 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 12 hours post-dose). |
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E.5.2 | Secondary end point(s) |
- FEV1 AUC0-4h standardised by time (L) and FEV1 AUC4-12h standardised by time (L);
- Peak FEV1 (L) in terms of absolute value;
- FVC AUC0-12h standardised by time (L) and peak (L).
- Adverse events and adverse drug reactions;
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
FEV1 and FVC at pre-dose within 60 min of the dose and at 10 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 12 hours postdose)
Adverse events and adverse drug reactions will be evaluated throughout the whole study from screening until follow-up. |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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LVLS, including follow-up contact |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 5 |