E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12. |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
|
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 |
In patients with poorly controlled asthma with evidence of persistent eosinophilic inflammation can the addition of extra inhaled corticosteroid that targets the distal airways improve asthma control and reduce the eosinophilic airway inflammation?
The primary endpoint will be the difference in sputum eosinophil count between active and placebo groups at 8 weeks. |
|
E.2.2 | Secondary objectives of the trial |
The secondary endpoints are differences in bronchial nitric oxide, alveolar nitric oxide, forced expiratory volume in 1 second (FEV1), blood eosinophil count, asthma symptoms, Asthma Control Questionnaire (ACQ) score, Asthma Quality of Life Questionnaire (AQLQ) score, number of exacerbations and use of oral steroid. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Non-smokers with refractory asthma (ACQ score ≥1.5 or requirement for oral steroids ≥twice per year despite treatment with high dose inhaled steroid and treatment with, or unsuccessful trial of, a long acting beta-2 agonist or leukotriene antagonist).
Sputum eosinophil count >3%
A response to a 2 week trial of oral steroids, defined as a reduction in ACQ score by 0.5, an increase in FEV1 of 200ml, or either normalisation or a fall in exhaled NO of ≥25 ppb. |
|
E.4 | Principal exclusion criteria |
Poor compliance with usual asthma treatment
Pregnancy, inadequate contraception or lactation
Active smoking or smoking history of >10 pack-years
Clinical diagnosis of ABPA or significant bronchiectasis
Another significant, active, medical co-morbidity
Use of a medication which interacts with ciclesonide (ketoconazole, itraconazole, ritonavir, nelfinavir) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The difference in sputum eosinophil count between active and placebo groups at 8 weeks. |
|
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 | Yes |
E.6.4 | Safety | No |
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) | 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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 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 | 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
|
The trial will end when the final subject has completed their 12 week follow-up visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |