Post-marketing observational study to compare the efficacy and safety of ImmulinaTM-800 as add-on therapy against standard of care in the management of patients with Chronic Obstructive Pulmonary Disease.

A Prospective, open-label, post-marketing, observational, multi-center, comparative study for assessment of effectiveness and safety of ImmulinaTM-800 as add-on to Standard of Care in the Treatment and Prophylaxis of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) - IMSA

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/07/020005

Enrollment

300

Registered

2019-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients providing written informed consent. 2. Patients aged 40-65 years (Both inclusive). 3. Patient must be a diagnosed case of Chronic Obstructive Pulmonary Disease.

Exclusion criteria

Exclusion criteria: 1. Those unable to provide written informed consent. 2. Females who are pregnant 3. Patients not willing to practice barrier contraception during the study period. 4. Patients with known history of active tuberculosis, Acquired Immunodeficiency Disease or autoimmune disorder. 5. Patients with known hypersensitivity to Pidotimod.

Design outcomes

Primary

Measure	Time frame
To determine the effectiveness of ImmulinaTM-800 as add-on to SoC for treatment and prophylaxis of AECOPD in terms of change in: â?¢ COPD classification of patient as per GOLD guidelines (2019 edition). Timepoint: 12 months	—

Secondary

Measure	Time frame
Change in mMRC dyspnea scaleTimepoint: 12 months;No. of episodes of AECOPDTimepoint: 12 months;No. of episodes of suspected ADRs in the study participants on ImmunilaTM-800Timepoint: 12 months;No. of episodes requiring antibiotic therapyTimepoint: 12 months;No. of episodes requiring hospitalization due to AECOPDTimepoint: 12 months;Subgroup analysis will be done to explore the impact of co-prescribed steroids on study resultsTimepoint: 12 months	—

Measure

Time frame

Change in mMRC dyspnea scaleTimepoint: 12 months;No. of episodes of AECOPDTimepoint: 12 months;No. of episodes of suspected ADRs in the study participants on ImmunilaTM-800Timepoint: 12 months;No. of episodes requiring antibiotic therapyTimepoint: 12 months;No. of episodes requiring hospitalization due to AECOPDTimepoint: 12 months;Subgroup analysis will be done to explore the impact of co-prescribed steroids on study resultsTimepoint: 12 months

—

Countries

India

Contacts

Public ContactDr Gaurav Mittal

Wockhardt Ltd

gmittal@wockhardt.com9324918220

Outcome results

None listed

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