Chronic Obstructive Pulmonary DiseaseNCT03282526
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
A study testing Whole body plethysmography in people with Chronic Obstructive Pulmonary Disease, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Whole body plethysmography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any patients with a diagnosis of:
- Bronchial asthma
- Bronchiectasis
- Respiratory failure
- Decompensated core pulmonale
- Chronic Obstructive Pulmonary Disease combined with any other respiratory disease
Trial locations and contacts
No sites are listed yet.
Gamal Mohamed Rabie contact
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Whole body plethysmography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body plethysmographyDiagnostic test
Also called Spirometry, Plain chest radiograph
Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing
| Study group | Role | What they receive |
|---|---|---|
| Whole body plethysmography | Experimental | Not described Receives: Diagnostic Test: Whole body plethysmography |
| spirometery | Active comparator | Not described Receives: Diagnostic Test: Whole body plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start30 Sep 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Bahaa El-Din Ali Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282526
- Sponsor's protocol ID
- PFTs in COPD
- Status last verified
- Aug 2017
- First submitted
- 26 Aug 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28668138"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.
PubMed 28642306
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Parameters Vs Flow Parameters In Assessment Of Reversibility In Stable Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT03282526
- Acronym / sponsor ID
- PFTs in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body plethysmography | Experimental | Diagnostic Test: Whole body plethysmography |
| spirometery | Active comparator | Diagnostic Test: Whole body plethysmography |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Bronchial asthma
- Bronchiectasis
- Respiratory failure
- Decompensated core pulmonale
- Chronic Obstructive Pulmonary Disease combined with any other respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body plethysmographyAlso: Spirometry, Plain chest radiographWhole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing | Diagnostic test | Whole body plethysmography, spirometery |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Results publication: PubMed 28668138Vogelmeier 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.
- Results publication: PubMed 28642306"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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal Mohamed Rabie contact
Questions about this trial
What is this clinical trial studying?
A study testing Whole body plethysmography in people with Chronic Obstructive Pulmonary Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AZZA BAHAA EL-DIN ALI (01090078962, zozo8928@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.