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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03282526
• Other study ID #: PFTs in COPD
• Status: Not yet recruiting
• Phase: N/A
• First received: August 26, 2017
• Last updated: September 12, 2017
• Start date: September 30, 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: AZZA BAHAA EL-DIN ALI
• Phone: 01090078962
• Email: zozo8928[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• Whole body plethysmography
Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

"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, Bartolom — View Citation

Vogelmeier CF, Criner GJ, Martínez 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, Rodríguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agustí A. Erra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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