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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Diagnostic Test: Whole body plethysmography

• Registration Number: NCT03282526
• Lead Sponsor: Assiut University

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).

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-26
• Study First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Study First Posted: 2017-09-14
• Last Update Posted: 2017-09-14
• Study Start: 2017-09-30
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole body plethysmography	Whole body plethysmography	-
spirometery	Whole body plethysmography	-

Primary Outcome Measures

Name	Time	Method
Assess the response pattern to inhaled short acting B2 agonist	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	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