Moderate to Severe Asthma. Severe persistent asthma
Conditions
Interventions
Intervention 1: Intervention group: Omalizumab manufactured by Behestan Darou Company (pre-filled syringe, 150 and 75 mg) every 2 or 4 weeks for 36 weeks, the dose is based on the patients body weight
Sponsors
Behestan Darou Company
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with moderate to severe persistent asthma, aged between 12 and 75 years , of both sexes Diagnosis of asthma greater than 1 year duration, or the clinical diagnosis of moderate to severe asthma by a physician The patient or the patient and his/her legal guardian (for patients under 18 years old) have the ability to understand the implementation processes of the study and correctly understand the explanations of the conductors and are able and willing to follow the study protocol throughout the entire study period, including visits, injections, and other study processes The patient or the patient and his/her legal guardian (for patients under 18 years old) must be able to fully understand the contents of the informed consent form and sign it before entering the study The patient must have a positive serum reactivity test or clinical evidence of allergic asthma Body weight of =30 to =150 kg Total serum IgE level of =30 and =700 IU/ml History of at least 2 asthma exacerbation which needed systemic corticosteroids in the 12 months prior to the screening visit despite the use of high doses of inhaled corticosteroids and LABA; or have one severe asthma exacerbation in which FEV1 or PEF is less than 60% of the patient's best condition and requires systemic corticosteroids and hospitalization FEV1 between 40-80, which can be increased by at least 12% with the use of Salbutamol During the last 3 months, patient has received ICS with a dose equivalent to 500-1200 Beclomethasone
Exclusion criteria
Exclusion criteria: Patients who intend to participate in another clinical trial during the study period A history of severe allergic reaction (swelling of the mouth and throat, shortness of breath, hypotension, hives, shock, etc.) to drug injection that required therapeutic interventions History of allergic reaction to Omalizumab or compounds used in the product formulation History of treatment with omalizumab in the past year Patients who had an asthma exacerbation within a month before the screening Patients who had an upper respiratory tract infection within two weeks before the screening Patients who smoke more than 22 packs/year Taking immunosuppressant medication (including Methotrexate and Cyclosporine) within three months before entering the study Women who are pregnant or lactating at the time of screening or intend to become pregnant during the study period Unwillingness to continuously use effective methods of preventing pregnancy during the study (women) Continuous use of oral corticosteroids (more than 20 mg daily) Presence of concomitant lung diseases such as PF, CF, bronchiectasis (if the patient has had a CXR in the past year, there is no need to repeat it) Increased IgE levels due to causes other than asthma (parasitic infection) Severe psychiatric disorders that would affect participation in the study Any other conditions outside the above cases that, in the investigator's opinion, make the individual unsuitable for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Asthma exacerbations over the 9 months. Timepoint: Based on the patient's injection intervals: four weeks injection intervals: screening visit and in weeks -4, -2, 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 38• two weeks injection intervals: screening visit and in weeks -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38. Method of measurement: Clinical Evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events during the study period (9 months). Timepoint: Based on the patients' injection intervals: four weeks injection intervals: 0, 1, 4, 5, 8, 9, 12, 13, 16, 17, 20, 21, 24, 25, 28, 29, 32, 33, 36, 37, 38. two weeks injection intervals: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38. Method of measurement: Evaluation of Adverse events through in-person visits, follow-up telenursing, paraclinical evaluation (laboratory and pulmonary function tests).;Number of patients with at least one asthma exacerbation. Timepoint: Based on the patients' injection intervals: four weeks injection intervals: screening visit and in weeks -4, -2, 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 38. two weeks injection intervals: screening visit and in weeks -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38. Method of measurement: Clinical Evaluation.;Change in spirometric parameters such as FVC, FEV1 before and after using a bronchodilator. Timepoint: Based on the patients' injection interval: four weeks injection intervals: screening visit and in weeks -4, -2, 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 38. two weeks injection intervals: screening visit and in weeks -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38. Method of measurement: Spirometry.;Measurement of IgE level at the end of the study. Timepoint: Screening and at week 38. Method of measurement: Evaluation of laboratory results.;Dosage of oral and inhaled corticosteroids. Timepoint: Based on the patients' injection intervals: four weeks injection intervals: screening visit and in weeks -4, -2, 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 38. two weeks injection intervals: screening visit and in weeks -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38. Method of measurement: Clinical Evaluation.;Change in Asthma Control Test score (ACT). Timepoint | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKeyvan Koohgir
Behestan Darou Company
Outcome results
None listed