E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Asthma and allergic rhinitis |
|
MedDRA Classification |
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 evaluate the effects of inmunotherapy with Alternaria alternata 1 on AMP bronchial answer and his increments, in asthmatic patients and in patients with allergenic rhinitis sensitized to this allergen. -To identificated the effects of inmunotherapy with Alternaria alternata 1 on exhaled nitric oxide concentrations and on increments of this inflammation marker due to the allergen natural exposition, in asthmatic patients and in patients with allergenic rhinitis sensitized to this micotic allergen. |
|
E.2.2 | Secondary objectives of the trial |
-To evaluate the effect of inmunotherapy with Alternaria alternata 1 on: -others markers as inflammation markers and oxidative stress markers (pH, hydrogen peroxide) -bronchial responsiveness to methacholine -respiratory functional parameters (VEMS,FVC, FEV1/FVC, FEF25-75) -seric cytocines
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Male and female patients, with age range 12-75 years, no smoking (6 months). -Diagnosis of asthma (American Thoracic Society criteria) or allergic rhinitis (conventional criteria), without severe exacerbations (during 3 months). -Treated during 12 previous weeths con short action beta2 -agonists or with a beclometasone dose equal or minor than 1000 microg/day or with budesonide dose equal or minor than 800 microg/day or with a fluticasone dose equal or minor than 500 microg/day. -Alternaria sensitized (with positive prick test) with or without others perenne allergens, but unsensitized to Parietaria or Chenopodiaceas (Chenopodium, Salsola) allergens.
|
|
E.4 | Principal exclusion criteria |
-Patients with evidence of severe disease (organic or psiquiatric), pregnancy,having participating in another clinical trial during 4 previous weeths, previous inmunotherapy, intake of corticosteroids during 3 previous months, inmunotherapy with others allergens. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Efficacy determinants: AMP concentration that induces a FEV1 deterioration of 20% (PC20) and exhaled nitric oxide concentrations. -Safety: clinical evaluations and monitoring of adverse effects.
|
|
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 | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To evaluate the inmunotherapy effects |
|
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
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) | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | 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
| |
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 | 21 |
E.8.9.1 | In the Member State concerned days | |