Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole body plethysmography
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Patients Clinical diagnosis of Chronic Obstructive Pulmonary Disease
- Must be able to do pulmonary function test
- Age more than 40 years
- Stable Chronic Obstructive Pulmonary Disease patients
Exclusion Criteria:
Any patients with a diagnosis of:
- Bronchial asthma
- Bronchiectasis
- Respiratory failure
- Decompensated core pulmonale
- Chronic Obstructive Pulmonary Disease combined with any other respiratory disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole body plethysmography
spirometery
Arm Description
Outcomes
Primary Outcome Measures
Assess the response pattern to inhaled short acting B2 agonist
Assess the response pattern to inhaled short acting B2 agonist through measuring flow and volume parameters to define the differences between volumes responders and flow responders
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03282526
Brief Title
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
Official Title
Volume Parameters Vs Flow Parameters In Assessment Of Reversibility In Stable Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2017 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Assess the differences between flow and volume responses after bronchodilator reversibility testing in patients over different clinical chronic obstructive pulmonary disease stages (GOLD stage I to GOLD stage IV).
Study the Correlation between the bronchodilator response and the severity of the disease.
Detailed Description
chronic obstructive pulmonary disease is a common preventable and treatable disease characterized by persistent airflow limitation that is usually progressive. The diagnosis requires an evidence of obstructive pattern by spirometry measured before and after bronchodilators.
The degree of reversibility of airflow obstruction differs between patients, and does not predict the response to bronchodilator therapy. It can be seen in terms of forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1),or Inspiratory capacity (IC) or residual volume (RV).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole body plethysmography
Arm Type
Experimental
Arm Title
spirometery
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole body plethysmography
Other Intervention Name(s)
Spirometry, Plain chest radiograph
Intervention Description
Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing
Primary Outcome Measure Information:
Title
Assess the response pattern to inhaled short acting B2 agonist
Description
Assess the response pattern to inhaled short acting B2 agonist through measuring flow and volume parameters to define the differences between volumes responders and flow responders
Time Frame
twice per day one before inhaled short acting B2 agonist and one after 10 minutes from inhaled short acting B2 agonist for average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients Clinical diagnosis of Chronic Obstructive Pulmonary Disease
Must be able to do pulmonary function test
Age more than 40 years
Stable Chronic Obstructive Pulmonary Disease patients
Exclusion Criteria:
Any patients with a diagnosis of:
Bronchial asthma
Bronchiectasis
Respiratory failure
Decompensated core pulmonale
Chronic Obstructive Pulmonary Disease combined with any other respiratory disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AZZA BAHAA EL-DIN ALI
Phone
01090078962
Email
zozo8928@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal Mohamed Rabie
Phone
01221729476
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28668138
Citation
Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DMG, Varela MVL, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Erratum to "Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary" [Arch Bronconeumol. 2017;53:128-49]. Arch Bronconeumol. 2017 Jul;53(7):411-412. doi: 10.1016/j.arbres.2017.06.001. No abstract available. English, Spanish.
Results Reference
result
PubMed Identifier
28642306
Citation
"Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary." Claus F. Vogelmeier, Gerard J. Criner, Fernando J. Martinez, Antonio Anzueto, Peter J. Barnes, Jean Bourbeau, Bartolome R. Celli, Rongchang Chen, Marc Decramer, Leonardo M. Fabbri, Peter Frith, David M.G. Halpin, M. Victorina Lopez Varela, Masaharu Nishimura, Nicolas Roche, Roberto Rodriguez-Roisin, Don D. Sin, Dave Singh, Robert Stockley, Jorgen Vestbo, Jadwiga A. Wedzicha and Alvar Agusti. Eur Respir J 2017; 49: 1700214. Eur Respir J. 2017 Jun 22;49(6):1750214. doi: 10.1183/13993003.50214-2017. Print 2017 Jun. No abstract available.
Results Reference
result
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Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
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