Health Condition 1: null- COPD
Conditions
Interventions
Intervention1: PIDOTIMOD 800 mg: All enrolled subjects would receive add-on therapy with Pidotimod 800mg twice daily for 8 days followed by 800mg once daily till completion of 2 months of therapy.
Con
Sponsors
Dr Ashish Omprakash Goyal
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult Patients (>= 18 years and 2. Patient who had two or more exacerbation of COPD that required antibiotics for therapy OR One or more exacerbation requiring hospitalization in last 12 months. 3. Patients with FEV1 = 30%. 4. Patients who are clinically stable (No episode of exacerbation) during one month prior to enrolment into study. 5. Patients who understand the nature of the study and are willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with known allergic / hypersensitivity reaction to study medication. 2. Patients who had received antibiotics or a course of systemic steroids (defined as equivalent to >10 mg of prednisone a day for more than 1 week) within month prior to enrolment in the study. 3. Patients suffering from asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing. 4. Patients known to be suffering from primary immunodeficiency / acquired immunodeficiency viz. HIV 5. Patients suffering from comorbid conditions that can affect the immune response viz. diabetes, Anaemia, Hypoalbuminemia. 6. Patients suffering from other respiratory disorders viz. tuberculosis 7. Patients suffering from such cardiovascular disorders viz. Uncontrolled hypertension, CVD; that may potentially complicate and pose risk to health of the patients 8. Patients with co-morbidities requiring medicines that can adversely interact with or interfere with evaluation of study medication. 9. Patients suffering from any renal, hepatic or neoplastic disorders 10. Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study. 11. Female subjects who are pregnant or are currently breast-feeding. 12. Subject who had participated in any clinical trials in past 2 months. 13. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the number of exacerbations of COPDTimepoint: 12 months post commencement of Pidotimod treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Average duration of each episode of exacerbation Number of episode requiring antibiotic therapy Average duration of antibiotic therapy required per episode Number of episodes requiring hospitalization Timepoint: 12 months post commencement of Pidotimod treatment. | — |
Countries
India
Contacts
Public ContactDr Ashish Omprakash Goyal
Lifepoint Multispeciality Hospital
Outcome results
None listed