Three Treatment of Chronic Obstructive Pulmonary Disease Patients

Comparative Study Between Three Therapeutic Options for Treatment of Chronic Obstructive Pulmonary Disease Patients

Sponsors

Lead Sponsor: Tanta University

Source 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 .

Overall Status Completed
Start Date October 31, 2014
Completion Date December 31, 2019
Primary Completion Date December 30, 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
FEV1 value three months
Tumer necrosis factor alpha ( TNF ) three months
Interlukin 6 ( IL6 ) three months
Fibrinogen Three months
Enrollment 45
Condition
Intervention

Intervention Type: Drug

Intervention Name: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid

Description: inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).

Arm Group Label: Group 1

Other Name: Budesonide/Formoterol

Intervention Type: Drug

Intervention Name: Tiotropium 18 mcg capsule inhaled once daily + Budesonide

Description: inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).

Arm Group Label: Group 2

Other Name: Tiotropium/ Budesonide

Intervention Type: Drug

Intervention Name: Formoterol/Tiotropium

Description: long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).

Arm Group Label: Group 3

Other Name: LABA /LAAC.

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Tarek M Mostafa, Ass. Prof. Principal Investigator Tanta University
Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Tanta University

Investigator Full Name: Dr. Tarek Mohamed Mostafa

Investigator Title: Associate Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Group 1

Type: Experimental

Description: 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).

Label: Group 2

Type: Experimental

Description: 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).

Label: Group 3

Type: Experimental

Description: 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)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: randomized double blind prospective study.

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Masking Description: double blind

Source: ClinicalTrials.gov