This is multi-center, known drug with no comparator drug, clinical study to evaluate safety and efficacy of OmaliRel™ in patients with moderate to severe persistent asthma.

Phase 4

Completed

• Conditions: Health Condition 1: J708- Respiratory conditions due to other specified external agents

• Registration Number: CTRI/2021/05/033508
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 220

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 < 80% of predicted normal value for the patient

(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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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