Three Treatment of Chronic Obstructive Pulmonary Disease Patients
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      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 .
    

Detailed description: 
      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 .
    

Intervention name(s): Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid; Tiotropium 18 mcg capsule inhaled once daily + Budesonide; Formoterol/Tiotropium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).; inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).; long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).
Other intervention name(s): Budesonide/Formoterol; Tiotropium/ Budesonide; LABA /LAAC.
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Tiotropium Bromide; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double blind prospective study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment