Safety And Efficacy of Abiways In Moderate to Severe Asthma And COPD Patients.

Phase 4

• Conditions: Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J454- Moderate persistent asthmaHealth Condition 3: J455- Severe persistent asthma

• Registration Number: CTRI/2023/06/053647
• Lead Sponsor: Mankind Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Aged between 18 to 65

2. Ready to sign an informed consent form or informed consent form signed by legally acceptable representatives.

3. Moderate - severe COPD patients (FEV1- 30-80%).

4. GINA 3-5 Asthma patients.

Exclusion Criteria

1. severely ill and mentally retarded patients who cannot converse properly.

2. Patients unable to complete the QoL questionnaire.

3. Patients are known or thought to be hypersensitive to the study drug.

4. History of auto-immune disease.

5. Concurrent use of corticosteroids

6. Any medication or indication that might point to an increased risk, associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion.

7. Participation in other clinical trials during study participation.

8. Patients with a history of epilepsy, or those at risk for seizures or taking seizure drugs.

9. Pregnant and lactating women.

10. Patients with severe renal impairment, including those receiving dialysis.

11. Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.

12. Patients admitted to ICU.

Study & Design

• Study Type: PMS
• Study Design: Not specified