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.
Phase 4
- Conditions
- Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
- Registration Number
- CTRI/2019/07/020005
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effectiveness of ImmulinaTM-800 as add-on to SoC for treatment and prophylaxis of AECOPD in terms of change in: <br/ ><br>â?¢COPD classification of patient as per GOLD guidelines (2019 edition). <br/ ><br>Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method 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