The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled Moderate to Severe Allergic Asthma All the participants will receive one of the following regimens: Omalizumab (CinnaGen) or Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland), as subcutaneous injections, Omalizumab was administered every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg/IgE for a duration of 28 weeks The primary objective of this study is to assess whether the efficacy of Omalizumab (CinnaGen, Iran) is equivalent to Xolair® (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) as measured by rate of protocol-defined asthma exacerbations during the 28-week treatment period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
256
Omalizumab (CinnaGen, Iran) was administered via subcutaneous injection
Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland) was administered via subcutaneous injection
Golestan Hospital
Ahvāz, Iran
Imam Khomeini
Ahvāz, Iran
Khorshid Hospital
Isfahan, Iran
Dr.Tavakoul Office
Karaj, Iran
Afzaalipour Hospital
Kerman, Iran
Dr.Mirsadraei Office
Mashhad, Iran
Qaem Hospital
Mashhad, Iran
Dr.Qalebaqi Office
Rasht, Iran
Razi Hospital
Rasht, Iran
Imam Khomeini Hospital
Sari, Iran
...and 12 more locations
Rate of protocol-defined asthma exacerbations during the 28-week treatment period
Protocol-defined asthma exacerbation (PDAE) is defined as worsening asthma symptoms requiring treatment with 40-50 mg oral corticosteroids for 3-7 days; for patients receiving long-term Oral Corticosteroids, an exacerbation is a 20-mg or more increase in the average daily dose of oral prednisolone (or a comparable dose of another oral corticosteroids)
Time frame: 28 weeks
Change in Asthma Control Test (ACT) score from baseline to the end (last four weeks) over the 28 weeks
Asthma Control Test (ACT) scores range from 5-25 (higher is better). Scores of 20-25 are classified as well-controlled asthma; 16-19 as not well-controlled; and 5-15 as very poorly controlled asthma.
Time frame: 28 weeks
Change in spirometry measures (FEV1) in 28 weeks
FEV1: Forced Expiratory Volume in the first second of exhalation
Time frame: 28 weeks
Immunogenicity Assessment
Number of participants positive for anti-drug antibodies at weeks 16 and 28
Time frame: 28 weeks
Evaluation of adverse events during 28 weeks
Time frame: 28 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.