Three Treatment of Chronic Obstructive Pulmonary Disease Patients
Primary Purpose
COPD
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid
Tiotropium 18 mcg capsule inhaled once daily + Budesonide
Formoterol/Tiotropium
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- Age from 30 to 40 years or older.
- Patient with 30%≥ FEV1<80% predicted and FEV1/FVC <70% predicted.
Exclusion Criteria:
- Patients with FEV1< 30% predicted or FEV1< 50% predicted plus chronic respiratory failure.
- Patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening.
- Patients with history of asthma.
- Patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm 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).
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: 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)
Outcomes
Primary Outcome Measures
FEV1 value
Forced expiratory volume in 1second (FEV1) value
Tumer necrosis factor alpha ( TNF )
serum level
Interlukin 6 ( IL6 )
serum level
Fibrinogen
serum level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04520230
Brief Title
Three Treatment of Chronic Obstructive Pulmonary Disease Patients
Official Title
Comparative Study Between Three Therapeutic Options for Treatment of Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2014 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Full medical history will be taken through clinical assessment of dyspnea, chronic cough and sputum production using mMRC or CAT test.
Forced expiratory volume in 1second (FEV1) value measurement using spirometry.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized double blind prospective study.
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm 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).
Arm Title
Group 2
Arm Type
Experimental
Arm 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).
Arm Title
Group 3
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid
Other Intervention Name(s)
Budesonide/Formoterol
Intervention Description
inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).
Intervention Type
Drug
Intervention Name(s)
Tiotropium 18 mcg capsule inhaled once daily + Budesonide
Other Intervention Name(s)
Tiotropium/ Budesonide
Intervention Description
inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).
Intervention Type
Drug
Intervention Name(s)
Formoterol/Tiotropium
Other Intervention Name(s)
LABA /LAAC.
Intervention Description
long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).
Primary Outcome Measure Information:
Title
FEV1 value
Description
Forced expiratory volume in 1second (FEV1) value
Time Frame
three months
Title
Tumer necrosis factor alpha ( TNF )
Description
serum level
Time Frame
three months
Title
Interlukin 6 ( IL6 )
Description
serum level
Time Frame
three months
Title
Fibrinogen
Description
serum level
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 30 to 40 years or older.
Patient with 30%≥ FEV1<80% predicted and FEV1/FVC <70% predicted.
Exclusion Criteria:
Patients with FEV1< 30% predicted or FEV1< 50% predicted plus chronic respiratory failure.
Patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening.
Patients with history of asthma.
Patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek M Mostafa, Ass. Prof.
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21810710
Citation
Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
Results Reference
background
PubMed Identifier
18453363
Citation
Falk JA, Minai OA, Mosenifar Z. Inhaled and systemic corticosteroids in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):506-12. doi: 10.1513/pats.200707-096ET.
Results Reference
background
PubMed Identifier
34306265
Citation
Mostafa TM, El-Azab GA, Atia GA, Lotfy NS. The Effectiveness of 3 Combined Therapeutic Regimens in Egyptian Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: A Randomized Double-Blind Prospective Pilot Study. Curr Ther Res Clin Exp. 2021 Mar 8;94:100625. doi: 10.1016/j.curtheres.2021.100625. eCollection 2021.
Results Reference
derived
Learn more about this trial
Three Treatment of Chronic Obstructive Pulmonary Disease Patients
We'll reach out to this number within 24 hrs