Three Treatment of Chronic Obstructive Pulmonary Disease Patients

August 18, 2020 updated by: Dr. Tarek Mohamed Mostafa, Tanta University

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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).
Drug: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid
inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).
Other Names:
  • Budesonide/Formoterol
Experimental: Group 2
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).
Drug: Tiotropium 18 mcg capsule inhaled once daily + Budesonide
inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).
Other Names:
  • Tiotropium/ Budesonide
Experimental: Group 3
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)
Drug: Formoterol/Tiotropium
long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).
Other Names:
  • LABA /LAAC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 value
Time Frame: three months
Forced expiratory volume in 1second (FEV1) value
three months
Tumer necrosis factor alpha ( TNF )
Time Frame: three months
serum level
three months
Interlukin 6 ( IL6 )
Time Frame: three months
serum level
three months
Fibrinogen
Time Frame: Three months
serum level
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Tarek M Mostafa, Ass. Prof., Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2014

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP00011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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