E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
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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 assess the bronchodilator effect of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma compared with placebo as measured by mean change in FEV1 from baseline to post-dose trough after 7 days of treatment. Trough is defined as the mean of FEV1 at 23 h 10 min and 23 h 45 min post-dose. |
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E.2.2 | Secondary objectives of the trial |
- To assess the bronchodilator effect of orally inhaled indacaterol salts in patients with persistent asthma compared with placebo - Morning and evening PEF measurements for indacaterol salts in comparison to placebo - To assess day and night rescue medication usage for indacaterol salts in comparison to placebo - To assess the safety and tolerability of indacaterol salts in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECGs - To evaluate the incidence of post-inhalational cough and tolerability, as determined by the investigator and the patient, after administration of indacaterol salts in comparison to placebo - To assess the pharmacokinetics of indacaterol after 7 days of treatment of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Non smoker male and female adult patients aged 18-75 years inclusive, who have signed an Informed Consent Form prior to initiation of any study-related procedure. 2) Patients with asthma, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2008) and who additionally meet the following criteria: a. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to screening. b. Patients with an FEV1 at Visit 1 of ≥50% of the predicted normal value for the patient. c. Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 μg/180 μg of salbutamol/albuterol MDI (or equivalent dose of DPI) (the reversibility test). 3) Women of child-bearing potential (WOCBP), unless they meet the definition of post-menopausal written in the Protocol OR have past 6 weeks from surgical bilateral oophorectomy OR are using one of the acceptable methods of contraception listed in the Protocol. 4) BMI must be within the range 18-32 kg/m2 (inclusive). 5) Vital signs not considered by the Investigator to be indicative of a disorder which would make it unsafe for subject to participate in the study or require medical intervention. |
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E.4 | Principal exclusion criteria |
1) A urine cotinine level greater then the local laboratory lowest level of quantification. 2) Patients who have had previous intubation for a severe asthma attack/exacerbation. 3) Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening. 4) Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening or any time between screening and per-dose day 1. 5) Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and per-dose day 1. 6) Patients with seasonal allergy whose asthma is likely to deteriorate during the study period. 7) Patients who require the use of ≥8 inhalations per day of the short-acting β2-agonist on any 2 consecutive days from screening to randomization. 8) Patients diagnosed with COPD. 9) Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis. 10) Any patient with lung cancer or a history of lung cancer. 11) Significant illness within the two weeks prior to dosing. 12) History of left-ventricular heart failure or symptomatic coronary atherosclerotic cardiovascular disease. 13) A past medical history of life-threatening arrhythmias or a history, or family history, of long QT syndrome. 14) Patients with a persistent systemic blood pressure ≥ 150/90 mmHg, measured on 2 separate occasions at least 24-hours apart. 15) Pregnant or nursing (lactating) women. 16) Patients with diabetes Type I or uncontrolled diabetes Type II. 17) Patients who have ever received or are currently receiving treatment with omalizumab. 18) Treatments for asthma and allied conditions with not allowed medicationslisted in the protocol prior to screening for at least the minimum period specified in the protocol or any time during the study. 19) The following treatments should not be used for the period specified in the protocol:  antihistamines  inhaled nasal cromolyn and inhaled nasal corticosteroids  maintenance immuontherapy (desensitization) for allergies  non-potassium-sparing diuretics  β-adrenergic antagonists  drugs with potential to significantly prolong the QT-interval  tricyclic antidepressants and monoamine oxidase inhibitors  anti-tussive medication  opiates. 20) Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to trough FEV1 after 7 days of treatment. Trough FEV1 is defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post dose. |
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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 | Yes |
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 | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
confronto tra i 3 diversi sali dell`indacaterolo |
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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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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
| |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |