A PROSPECTIVE, COMPARATIVE STUDY OF EFFECT OF ROFLUMILAST IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND ITS EFFICACY IN REDUCING ACUTE EXACERBATIONS.

D. thamizh Vani, Malar Sivaraman

Abstract


Aim:

To study the efficacy of Roflumilast as an add on therapy and to reduce exacerbations in COPD.

 Objective:

To determine whether Roflumilast improves lung function and decreases exacerbation frequency over a period of 6 months in patients with COPD.

Method: This was a prospective, comparative, randomized, open label study. Patients attending outpatient department of Thoracic medicine diagnosed with COPD with FEV1/FVC < 0.7 were recruited and divided into 2 groups of 50 patients each. Group 1 was administered with standard treatment consisting of Salmeterol and steroid inhalation, while Group 2 patients were administered Roflumilast 500 microgm once daily as add on therapy. Patients were followed every week and enquired for exacerbations and adverse effects. Lung function tests were performed every month using spirometer.

Results: 24 participants were female and the rest 76 were male. There was improvement seen in lung function tests in Roflumilast group compared to control group. All patients in Roflumilast group reported improvement in symptoms such as cough, breathlessness and increase in sputum production and in quality of life compared to control group. Exacerbation of COPD was seen in 3 patients in Roflumilast group compared to 9 patients in control group. The median time to exacerbation was 4.3 months in Roflumilast group compared to 2.8 months in control group.

Conclusion: Data suggest that roflumilast reduces moderate to severe exacerbations with the benefit most well established in patients with severe disease.


Keywords


Roflumilast, Exacerbation, spirometer

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