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The Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma
Bu çalışma, alerjik astımı (allergic asthma) olan hastalarda ev tozu akarına (house dust mite) karşı uygulanan alerjen immünoterapisinin (dil altı ODACTRA tableti) antiviral bağışıklık üzerindeki etkisini plasebo ile karşılaştırarak incelemektedir. Astım tanısı doğrulanmış, ev tozu akarına duyarlı, 18-65 yaş arası hastalar katılabilmiştir. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Subjects must meet all the following criteria:
INCLUSION CRITERIA
1. Written informed consent
2. Age ≥18 through ≤ 65, inclusive at the time of V1
3. A historic verified diagnosis of asthma as defined by 1 positive of following tests:
1. Reversibility to Beta-2-agonist
2. Positive mannitol challenge test
3. Positive methacholine test
4. Positive peak-flow variation test
5. Positive eucapnic voluntary hyperventilation test
6. Exercise test
4. Mild to severe symptoms of of HDM induced rhinitis for at least one year (acc. ARIA 2008 Bousqet et al. 2008).
5. ≥1 self-reported worsening of asthma symptoms in relations to viral infection within last 12 months
7\. A postbronchodilator FEV1 value of ≥ 70% at V1
8\. ACQ-6 ≥ 1 at V1
9\. A stable asthma controller regimen with ICS for at least 4 weeks prior to V1 (GINA 2-4)
10\. Daily dose of ICS at V1 (budesonide equivalent) ≥400µg 11. Sensitisation to HDM defined by one of the following:
1. Positive skin prick test defined as a wheel diameter ≥ 3 mm for either: Dermatophagoides pteronyssinus or Dermatophagoides farina
OR
2. IgEHDM \> 0.7 x103 IU/L
12\. Subjects must demonstrate acceptable inhaler and spirometry techniques during screening (as evaluated and in the opinion of study site staff)
EXCLUSION CRITERIA
Any of the following would exclude the subject from participation in the study:
1. Oral corticosteroids (any dose for more than 3 days) 8 weeks prior to V1 and during run-in.
2. Acute upper or lower respiratory infections requiring antibiotics or antiviral medications 6 weeks prior to V1 and during run-in.
3. Severe oral conditions such as but not limited to:
1. Oral ulcers
2. Oral lichen planus
3. Oral mycosis
4. Smoking any kind
1. Quit \> 6 months prior to V1.
2. ≥ 10 pack years
5. Positive skin prick test defined as a wheel diameter ≥ 3 mm:
a. Alternaria, Cladosporium, Aspergillus
6. Positive skin prick test defined as a wheel diameter ≥ 3 mm for- and with anamnestic relevant exposure to:
a. Cat, Dog, Horse
7. Ever in treatment with any AIT
8. Previous medical history or evidence of an uncontrolled intercurrent illness such as but not limited to (e.g. Autoimmune disease, immunodeficiency, immunosuppression, malignant neoplastic conditions with current relevance) that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidaemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to V1 are eligible.
9. Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, alpha-1-antitrypsin deficiency, Wegeners granulomatosis, Sarcoidosis).
10. Any clinically relevant abnormal findings in haematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
11. Evidence of active liver disease, including jaundice, alanine transaminase, bilirubin, greater than twice the upper limit of normal (laboratory results from V1).
12. History of cancer:
1. Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to V1.
2. Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to V1.
13. A helminth parasitic infection diagnosed within 24 weeks of V1 that has not been treated or has not responded to standard of care therapy.
14. Known history of active tuberculosis (TB). Subjects may be enrolled if they have ALL of the following:
1. No symptoms of TB: productive, prolonged cough (\> 3 weeks); coughing up blood; fever; night sweats; unexplained appetite loss; unintentional weight loss.
2. No known exposure to a case of active TB after most recent prophylaxis (prophylaxis required only if positive).
3. No evidence of active TB on chest radiograph within 3 months prior to the first dose of investigational product.
15. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol.
16. A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
17. History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or IgG subclass deficiency.
18. Use of 5-lipoxygenase inhibitors (eg, zileuton) within 15 days prior to V1.
19. Use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to V1.
20. Receipt of any of the following within 30 days prior to V1:
1. Immunoglobulin or blood products, or
2. Receipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior Visit 1, whichever is longer.
21. Receipt or treatment with of any marketed or investigational biologic agent within 6 months or 5 half-lives prior to V1, whichever is longer, specifically:
1. Anti-IgE
2. Anti-IL4
3. Anti-IL-5
4. Anti-IL5 receptor antagonist
5. Anti-IL-13
22. Pregnant, breastfeeding or lactating females
23. History of chronic alcohol or drug abuse within 12 months prior to V1.
24. Planned surgical procedures requiring general anaesthesia or in-patient status for \> 1 day during the conduct of the study.
25. Unwillingness or inability to follow the procedures outlined in the protocol.
26. Concurrent enrolment in another clinical study involving an investigational treatment.
27. Receipt of the Th2 cytokine inhibitor Suplatast Tosilate within 15 days prior to V1.
28. Receipt of any live or attenuated vaccines within 15 days prior to V1