A study for the uses and side effects of corticosteroids and bronchodilator drugs in people with airway problems

Not yet recruiting

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2019/10/021728
• Lead Sponsor: DEPARTMENT OF PHARMACOLOGY

Brief Summary

This is a prospective, open randomized parallel group comparative study to evaluate the efficacy and safety profile of Budesonide Formoterol Combination  versus Fluticasone Salmeterol Combination in Chronic Obstructive Pulmonary Disease patients. The study will be conducted for a duration of one and half year from date of approval from Ethics Committe of Govt. Medical College, Patiala. The study includes 80 patients, 40 patients in each group (group I and group II) coming to Department of Pulmonary Medicine, Government Tb Hospital attached to Government Medical College, Patiala. Patients from each group (BFC and FSC),  diagnosed by GOLD criteria, fulfilling the inclusion criteria and having none of exclusion criteria, will be enrolled in the study after obtaining the written informed consent. In group I, patients will receive Budesonide Formoterol combination (BFC) 200/6 or 400/6 microgm 2 puffs OD. In group II, patients will receive Fluticasone Salmeterol combination (FSC ) 250/50 microgm 2 puffs OD. The therapeutic efficacy of drugs will be evaluated by spirometric indices (FEV1,FVC and FEV1/FVC). Adverse drug reactions will be monitored in patients. Effectiveness of the drugs will be evaluated by change in spirometric indices (FEV1,FVC and FEV1/FVC). All the observations thus made, will be statistically analyzed using appropriate tests.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-10-18
• Study Start: 2019-10-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patient age more than 40 years.
• At least 1 inpatient visit with a primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC < 0.70).
• At least 1 ED visit with a COPD diagnosis (either primary or secondary).
• Patient on inhalational therapy – 2-3 weeks.

Exclusion Criteria

• Patient diagnosed with asthma or other non-COPD respiratory disorder.
• Any previous lung volume reduction surgery AND/OR lung transplantation.
• 3.A requirement for oxygen therapy for at least 12 hours per day.
• Any exclusionary co-morbid medical condition (cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, or any other condition likely to cause death within 3 years.
• Current use of oral/injectable corticosteroid therapy.
• Patients (diagnosed with cancer) who received ≥ 180 days of oral corticosteroids (OCS) in the 12-month pre-index period.
• Patients who initiated both study medications on the same date.
• Immuno-compromised (HIV +ve) patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Spirometric indices (FEV1,FVC and FEV1/FVC) of COPD patients on Budesonide/formoterol combination versus Fluticasone /salmeterol combination.	Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
To monitor the side effects of both Budesonide/formoterol combination and Fluticasone/salmeterol combination.	4 weeks

Trial Locations

Locations (1)

Government TB Hospital Attached to Government Medical College, Patiala.; 🇮🇳 Patiala, PUNJAB, India

Government TB Hospital Attached to Government Medical College, Patiala.

🇮🇳Patiala, PUNJAB, India

DR AMRIT PAL KAUR

Principal investigator

7696194100

dramrit24@gmail.com