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Comparative Study Between Three Therapeutic Options for Treatment of Chronic Obstructive Pulmonary Disease Patients
Forty five COPD patients will be recruited from Chest Disease Department, Tanta University Hospital, Tanta, Egypt. The aim of the study is to Compare between the effectiveness of three therapeutic options for treatment of moderate and severe COPD patients .These therapeutic options include Inhaled corticosteroid (ICS) plus long acting B2-agonist (LABA) combination, Inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) combination and Long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC) combination .
This study will be prospective randomized double blind study. The forty five COPD patients will be divided into three groups: Group 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ). Group 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ). Group 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC). If any worsening of dyspnea, increase of purulence, or increase of sputum production appear plus increase of peak variability more than 35% and FEV1 that necessitate a change of the regular drug medication of the patient will be recorded as exacerbation. All patients will be submitted to the following analysis at the baseline, during and 12 weeks after the assigned treatment: 1. Full medical history will be taken through clinical assessment of dyspnea, chronic cough and sputum production using mMRC or CAT test. 2. Forced expiratory volume in 1second (FEV1) value measurement using spirometry. 3. Measurement of the following inflammatory markers in serum and/ or plasma of patients under study . * Tumer necrosis factor alpha ( TNF ) * Fibrinogen * Interlukin 6 ( IL6 ) Statistical analysis The results will be statistically calculated to evaluate its clinical significance if any before ,during and after drug therapy using (ANOVA) system SPSS version 20 (2012) to compare between the three groups of patients and paired t-test will be used to compare between results before, during and after drug therapy .
Age
30 - 70 years
Sex
ALL
Healthy Volunteers
No
Start Date
October 31, 2014
Primary Completion Date
December 30, 2019
Completion Date
December 31, 2019
Last Updated
August 20, 2020
45
ACTUAL participants
Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid
DRUG
Tiotropium 18 mcg capsule inhaled once daily + Budesonide
DRUG
Formoterol/Tiotropium
DRUG
Lead Sponsor
Tanta University
NCT07477600
NCT07462221
NCT07351929
Data Source & Attribution
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