NCT03282526

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 14, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 26, 2017

Last Update Submit

September 12, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Whole body plethysmography

EXPERIMENTAL
Diagnostic Test: Whole body plethysmography

spirometery

ACTIVE COMPARATOR
Diagnostic Test: Whole body plethysmography

Interventions

Whole body plethysmographyDIAGNOSTIC_TEST

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

Also known as: Spirometry, Plain chest radiograph
Whole body plethysmographyspirometery

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any patients with a diagnosis of:
  • Bronchial asthma
  • Bronchiectasis
  • Respiratory failure
  • Decompensated core pulmonale
  • Chronic Obstructive Pulmonary Disease combined with any other respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 28668138RESULT

  • "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.

    PMID: 28642306RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Plethysmography, Whole BodySpirometry

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PlethysmographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory System

Central Study Contacts

AZZA BAHAA EL-DIN ALI

CONTACT

01090078962zozo8928@yahoo.com

Gamal Mohamed Rabie

CONTACT

01221729476

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2017

First Posted

September 14, 2017

Study Start

September 30, 2017

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

September 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share