Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease

Volume Parameters Vs Flow Parameters In Assessment Of Reversibility In Stable Chronic Obstructive Pulmonary Disease Patients

• 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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: Whole body plethysmography

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AZZA BAHAA EL-DIN ALI; Phone Number: 01090078962; Email: zozo8928@yahoo.com
• Study Contact Backup: Name: Gamal Mohamed Rabie; Phone Number: 01221729476

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole body plethysmography	Diagnostic test: Whole body plethysmography; Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing; Other Names: Spirometry; Plain chest radiograph
Active Comparator: spirometery	Diagnostic test: Whole body plethysmography; Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing; Other Names: Spirometry; Plain chest radiograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• "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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 26, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PFTs in COPD

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