Role of Roflumilast for Improvement of Lung Function in Chronic Obstructive Pulmonary Disease Patients

Md. Sahen, Mahmud Rahim, Md. Khairul Hassan Jessy, Syed Rezaul Huq, Mohammad Abdus Shakur Khan, Mahmud Masum Attar, Md. Ali Hossain,Md. Rashidul Hassan, Md. Mostafizur Rahman, Sanchay Kumar Biswas,Md. Alauddin, Muhammad Touhidul Islam Khan

Abstract:
Background: Current pharmacotherapy for chronic obstructive pulmonary
disease (COPD) has limited clinical efficacy so that patients often remain
symptomatic. Roflumilast an oral, selective phosphodiesterase-4 inhibitor
has been shown to improve lung function in COPD patients. General objectives
were to evaluate the effect of Roflumilast on improvement of lung function of
COPD. Specific objectives was to evaluate the effect of Roflumilast on FEV1
and to evaluate improvement of symptoms by COPD Assessment Test (CAT)
Methods: A single blind, randomized, prospective placebo controlled trial
was carried out in the department of Respiratory medicine at National
Institute of Diseases of the Chest and Hospital (NIDCH), Mohakhali, Dhaka.
A total number of 130 samples were collected from both inpatient department
and outpatient department (OPD). Among them 46 patients in group-A and
50 patients in group-B came to final follow-up. Group-A patients got
Roflumilast (0.5 mg single time daily x 3 months) with conventional therapy
(Inhaled Tiotropium-18ìg, Salmeterol-50 ìg, and Fluticason-500 ìg) and Group-
B patients got placebo with conventional therapy (Inhaled Tiotropium-18 ìg,
Salmeterol-50 ìg, and Fluticason-500 ìg). A spirometry and CAT (COPD
assessment test) score was performed in each case at the beginning and monthly
for consecutive 3 months. Difference of mean FEV1 and CAT-score from
baseline between two groups was measure to assess the Roflumilast activity.
The primary outcome variable was change in mean FEV1 and secondary
outcome variable was change in mean CAT score from base line.

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