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 | 15.1 |
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 superiority of indacaterol acetate 75 or 150 μg to placebo with respect to 24 h postdose trough FEV1 after 12 weeks of treatment in patient with persistent asthma.
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E.2.2 | Secondary objectives of the trial |
To demonstrate superiority of indacaterol acetate 75 or 150 μg to placebo with respect to ACQ-5.
To evaluate the bronchodilator effects of each dose of indacaterol acetate (75 and 150 μg) compared with placebo.
To evaluate the efficacy of indacaterol acetate (75 and 150 μg) compared with placebo in terms of asthma exacerbation-related parameters.
To evaluate the effect of each dose of indacaterol acetate (75 and 150 μg) compared with placebo on (pre-medication) morning and evening peak expiratory flow rate (PEFR).
To evaluate the effect of each dose of indacaterol acetate (75 and 150 μg) compared with placebo on rescue medication usage.
To assess the pharmacokinetics (PK) of each dose of indacaterol (75 and 150 μg).
To evaluate the efficacy of indacaterol acetate (75 and 150 μg) compared with placebo in terms of asthma exacerbation-related parameters.
To assess the safety and tolerability of each dose of indacaterol acetate (75 and 150 μg). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
- Patients who are receiving ICS treatment in a stable regimen for greater than or equal to 4 weeks
- Patients with a pre-bronchodilator FEV1 value of greater than or equal to 40% and less than or equal to 80% of predicted normal value
- Patients who demonstrate an increase of greater than or equal to 12% and 200 mL in FEV1
- ACQ-5 score greater than or equal to 1.5
*Other protocol-defined inclusion criteria may apply
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E.4 | Principal exclusion criteria |
- Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
- Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
*Other protocol-defined exclusion criteria may apply
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E.5 End points |
E.5.1 | Primary end point(s) |
Trough Forced Expiratory Volume in one second (FEV1).
Outcome Measure Description: Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Asthma Control Questionnaire 5 (ACQ-5).
Trough FEV1.
Forced vital capacity (FVC) at each timepoint.
FEV1/FVC at each timepoint.
Standadized FEV1 AUC(5 min – 4 h), (5 min – 1 h) and (1 h – 4 h).
Peak FEV1.
Morning and evening peak expiratory flow rate (PEFR).
The usage of rescue medication (short acting β2-agonist).
Asthma Quality of Life Questionnaire (AQLQ(S)).
Adverse events, laboratory analysis, vital signs and ECG.
Morning and evening peak expiratory flow rate (PEFR).
Plasma Indacaterol concentrations at each timepoint.
Time to first asthma exacerbation (mild, moderate, severe, moderate or severe and any) during the 12 week treatment period.
The annual rate of asthma exacerbations (mild, moderate, severe, moderate or severe and any).
Duration of asthma exacerbations (mild, moderate, severe, moderate or severe and any).
The percentage of patients with at least one asthma exacerbation (mild, moderate, severe, moderate or severe and any).
Time to permanent study discontinuation due to asthma exacerbation.
The percentage of patients who permanently discontinued study due to asthma exacerbation.
Total amounts (in doses) of systemic corticosteroids used to treat asthma exacerbations. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 70 |
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 | No |
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 |
Bulgaria |
Canada |
Germany |
Japan |
Korea, Republic of |
Netherlands |
Poland |
Slovakia |
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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 | 8 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |