Three Treatment of Chronic Obstructive Pulmonary Disease Patients

Phase 4

Completed

• Conditions: COPD
• Interventions: Drug: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid; Drug: Tiotropium 18 mcg capsule inhaled once daily + Budesonide; Drug: Formoterol/Tiotropium

• Registration Number: NCT04520230
• Lead Sponsor: Tanta University

Brief 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 .

Study Timeline

• Study Start: 2014-10-31
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-31
• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Study First Posted: 2020-08-20
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Age from 30 to 40 years or older.
2. Patient with 30%≥ FEV1<80% predicted and FEV1/FVC <70% predicted.

Exclusion Criteria

1. Patients with FEV1< 30% predicted or FEV1< 50% predicted plus chronic respiratory failure.
2. Patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening.
3. Patients with history of asthma.
4. Patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid	Group 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination (160/4.5mcg) 2 inhalations bid).
Group 2	Tiotropium 18 mcg capsule inhaled once daily + Budesonide	Group 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg inhaled capsule once daily+ Budesonide inhalation 200 mcg twice daily).
Group 3	Formoterol/Tiotropium	Group 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC). (Tiotropium 18 mcg inhaled capsule once daily+ Formoterol 12 mcg inhaled capsule twice daily)

Primary Outcome Measures

Name	Time	Method
FEV1 value	three months	Forced expiratory volume in 1second (FEV1) value
Tumer necrosis factor alpha ( TNF )	three months	serum level
Interlukin 6 ( IL6 )	three months	serum level
Fibrinogen	Three months	serum level