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

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ClinicalTrials.gov Identifier: NCT03282526
Recruitment Status : Not yet recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Azza Bahaa El-Din Ali Mohamed, 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Diagnostic Test: Whole body plethysmography Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Volume Parameters Vs Flow Parameters In Assessment Of Reversibility In Stable Chronic Obstructive Pulmonary Disease Patients
Estimated Study Start Date : September 30, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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




Primary Outcome Measures :
  1. Assess the response pattern to inhaled short acting B2 agonist [ 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 ]
    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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282526


Contacts
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Contact: AZZA BAHAA EL-DIN ALI 01090078962 zozo8928@yahoo.com
Contact: Gamal Mohamed Rabie 01221729476

Sponsors and Collaborators
Assiut University

Publications of Results:
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Responsible Party: Azza Bahaa El-Din Ali Mohamed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03282526     History of Changes
Other Study ID Numbers: PFTs in COPD
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases