| 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 | M15 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10003558 |
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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 that Depigoid as combination therapy with Omalizumab, compared to Depigoid monotherapy, has superior efficacy as for daily symptom load in adult and adolescent patients sensitized against grass pollen allergens with (not adequately controlled and therefore symptomatic) seasonal allergic asthma and comorbidity with seasonal allergic rhinoconjunctivitis. |
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| E.2.2 | Secondary objectives of the trial |
To evaluate whether Depigoid in combination with Omalizumab is superior to Depigoid monotherapy on:
Asthma/Rhinoconjunctivitis rescue medication score
Asthma/Rhinoconjunctivitis symptom severity score
Asthma symptoms assessed by the Asthma Control Questionnaire (ACQ, Juniper, 1999)
Global Evaluation of Treatment Effectiveness by investigator and patient
Asthma-related quality of life [AQLQ] (Juniper, 1999)
Rhinitis-related quality of life [RQLQ] (Juniper , 1999)
Work Productivity and Activity Impairment – Allergic Asthma measured by WPAI-AA (or Adolescent Productivity Impairment Evaluation)
Lung function (FEV1, PEF)
Bronchial hyperreactivity (PC20)
Systemic reactions to immunotherapy (according to DGAI)
Local reactions to immunotherapy
|
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
1. patients who (or as appropriate whose legal guardian) have been informed of the study procedures and medications and have given written informed consent
2. males or females of any race
3. who are 12 -45 years of age
4. with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing as provided in Tables 6-1 and 6-2)
5. with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pol-len) allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within > 2 previous seasons. Seasonal asthma is considered not adequately controlled if the pa-tient describes having had symptoms of seasonal asthma within > 2 previous seasons.
6. a positive RAST (>CAP2) result for grass pollen (and/or rye pollen) specific IgE at screening (V1) or within the previous 12 months.
7. with FEV1 > 80% of the predicted normal value for the patient at screening [V1](demonstrable at least 6 hours after last short acting -2 agonist use or 12 hours after last long -2 acting agonist use).
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|
| E.4 | Principal exclusion criteria |
Females of childbearing potential: pregnancy, birth control, breast-feeding
1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
2. Women of child-bearing potential
3. patients who have received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1 or who are likely to require systemic steroids for reasons other than asthma during the course of the study.
4. who are taking ß adrenergic antagonist medication (e.g.: propranolol) or anticipate use during the study.
5. who are taking methotrexate, gold salts, cyclosporin or troleandomycin within 3 months of Visit 1 (or anticipated their use during the study).
6. who are taking oral or inhaled anticholinergics within 24 hours of Visit 1.
7. concomitant treatment with substances interfering with the immune system.
Concurrent diseases/conditions and history of other diseases/conditions
8. patients with severe persistent allergic asthma.
9. who have a positive history for significant clinical manifestations of allergy as a result of sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite).
10. who are being treated for an asthma exacerbation during the 2 weeks prior to randomi-zation.
11. with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
12. with a history of allergy to antibiotics. Patients may be included if the antibiotics to which they are allergic will be avoided for the duration of the study.
13. with aspirin or non steroidal anti-inflammatory drug (NSAID) related asthma diag-nosed from the patients history.
14. who have a smoking history > 10 pack years.
15. with an active lung disease other than allergic asthma (e.g.: chronic bronchitis, COPD).
16. with elevated serum IgE levels for reasons other than allergy (e.g.: parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or clinical allergic bronchopulmonary aspergillosis).
17. patients with significant acute or chronic underlying medical conditions that could im-pact interpretation of results should be excluded (e.g.: infection, inflammatory disease, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months.
18. History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
19. with acute sinusitis or chest infection within 1 month of Visit 1 (e.g.: history of viral upper respiratory infection symptoms which did not resolve after 7-10 days or required treatment with antibiotics within 1 month of Visit 1).
20. with clinically significant laboratory abnormalities (not associated with the study indi-cation) at Visit 1.
21. Immune deficiencies, or immunopathological diseases (e.g. of the liver, kidney, nerv-ous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role.
22. Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism).
Investigational drug/therapy use
23. who have previously been randomized into this or any other Omalizumab study or who have received Omalizumab (prescribed).
24. who have been treated with specific immunotherapy within 5 years of V1.
25. Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half lifes of enrolment, whichever is longer.
Ingredient hypersensitivity
26. with known hypersensitivity to any ingredients, including excipients (sucrose, his-tidine, polysorbate 20) of the study medication, any immunotherapy, or drugs related to Omalizumab (e.g.: monoclonal antibodies, polyclonal gamma globulin).
27. with hypersensitivity to the trial’s asthma rescue- or escalation-medication or related drugs.
Compliance, reliability and investigator judgment
28. who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
29. with serious psychiatric and/or psychological disturbances.
30. with a history of drug or alcohol abuse.
31. who are unable to perform spirometry and peak flow measurements, complete a pa-tient diary or note book or complete questionnaires on paper
32. with any other condition or prior/current treatment, which in the opinion of the inves-tigator renders the patient ineligible for the study schedule.
33. involved in disease-related litigation.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Primary efficacy parameter: mean daily symptom load. The daily symptom load is defined as the daily combined asthma and rhinoconjunctivitis symptom severity score plus the daily asthma rescue medication score. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | Yes |
| 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 | Information not present in EudraCT |
| 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 | 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) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| 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.8.5 | 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 | 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
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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 | 7 |
| E.8.9.1 | In the Member State concerned days | |
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