Health Condition 1: J708- Respiratory conditions due to other specified external agents
Conditions
Interventions
Intervention1: OmaliRel: at Week 0,Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24.
Dose: The recommended dose of Omalizumab for adult patients w
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient with the diagnosis of moderate to severe persistent asthma >1 year duration and who have the history of the following : - Patients with a positive prick skin test to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 1 year or at screening. - Patients with total serum IgE level 76 to 700 IU/ml. - Patients demonstrating 12% increase in FEV1 and 200mL of absolute value of FEV1 over baseline value within 20-30 minutes of taking up to 4 puffs of Short-Acting Beta Agonists (SABA) documented within the past year or at screening or at baseline prior to dosing. - Patients with FEV1 (demonstrable at least 6 hours after short acting B-2 agonist use or 12 hours after long acting B-2 agonist use) at baseline. - >1 documented severe asthma exacerbations despite daily high dose ICS plus LABA (long acting inhaled ß2-agonist) within one year prior to screening Note: 1). Patients who do not have documentation of reversibility and/or skin prick test in previous one year, will have to undergo tests at screening. 2). The patients should meet all of the above criteria to be included in the study. 3). Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements. 4). Subjects must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires. 5). Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication 6). Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
Exclusion criteria
Exclusion criteria: 1. Any Clinically significant abnormal laboratory investigations or physical examination findings which may pose risk to the patients as assessed by investigator at screening visit. 2. Prior Hospitalisation or an emergency visit for asthma within the 4 weeks before the screening Visit. 3. Patient with history of near fatal or life-threatening (including intubation) asthma within the past year prior to screening visit. 4. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Omalizumab or its any excipients. History of illicit drug use within one year prior to screening. 5. Prior use of Omalizumab (or any biological treatment of Allergic Asthma) 6. Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit. 7. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis etc.). 8. Subject has a smoking history equivalent to 10 pack years (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.). 9. Current smoker or smoking history within 12 months prior to the Screening Visit. 10. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study. 11. Inability to comply with study and/or follow-up procedures. 12. Subjects with HIV, HBsAg, HCV test positive. 13. History or presence of any form of cancer within the 10 years prior to screening. 14. Participation in any clinical study of an investigational product within the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events occurring during the studyTimepoint: at Week 0,Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24 and Week 26 Sf/u | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of clinically significant exacerbation during the studyTimepoint: at Week 0,Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24 and Week 26 Sf/u;Mean Change in pulmonary function tests measured by FEV1 and FEV1/FVCTimepoint: at 12 and 24 weeks;Mean change in total asthma symptom scoreTimepoint: at week 12 and 24 from baseline.;Overall proportions of responders with meaningful Asthma Quality of Life Questionnaire (AQLQ) improvementsTimepoint: at week 12 and 24.;Proportion of patients in each category of Evaluation of Treatment EffectivenessTimepoint: at 12 and 24 weeks;Proportion of patients with Reductions in ICS dosesTimepoint: at 12 and 24 weeks;Reductions in ICS dosesTimepoint: at 12 and 24 weeks;Safety assessment – Incidence of treatment emergent adverse events (AEs) and Serious Adverse Events (SAEs)Timepoint: at Week 0,Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24 and Week 26 Sf/u;Safety evaluation will be based on physical examination, vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), laboratory investigations and adverse eventsTimepoint: at Week 0,Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24 and Week 26 Sf/u;Time to first asthma exacerbationTimepoint: till 12 and 24 weeks.;Immunogenicity assessmentTimepoint: at week 0, 12, 24 or at withdrawal visit | — |
Countries
India
Contacts
Public ContactVikram Jadhav
Reliance Life Sciences.
Outcome results
None listed