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

Combination of Acetylcysteine And Acebrophylline In Moderate to Severe Asthma And COPD Patients. - CARE

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/06/053647

Enrollment

100

Registered

2023-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: J454- Moderate persistent asthma Health Condition 3: J455- Severe persistent asthma

Interventions

Intervention1: Acebrophylline 100 mg, Acetylcysteine 600 mg oral: Acebrophylline 100 mg + Acetylcysteine 600 mg oral tablets BID for 90 days as an add-on treatment to the standard treatment. Control I

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To see improvement in â??Quality of Lifeâ?? based on a validated questionnaire. CAT and ACT (for COPD and asthma respectively). Safety - To observe the proportion of participants with adverse events and serious adverse events.Timepoint: 90 days	—

Secondary

Measure	Time frame
To observe the change in Forced Vital Capacity (FVC) from baseline.Timepoint: 90 days;To see improvement in forced expiratory volume in 1 second (FEV1).Timepoint: 90 days	—

Countries

India

Contacts

Public ContactDr Raja Dhar

CK Birla Hospital Department of Pulmonology

docaardee@yahoo.com9831855512

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026