COPDNCT03274791
Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD
An observational study of COPD and Airway Obstruction, run by Ministry of Scientific Research, Tunisia.
Trial summary
The aim of this study was to investigate the airway inflammatory profile and the clinical presentation of chronic obstructive pulmonary disease (COPD) in never smokers compared to smokers with COPD. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Airway Obstruction, Inflammation
- What is being tested?
- Analysis of induced sputum, Lung Function test and Enzyme-linked Immunosorbent Assay
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jan 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were recruited from the department of physiology and functional explorations of Sousse University Hospital. 40 subjects with COPD, according to GOLD criteria (21 current smokers and 19 never smokers) and 28 healthy control subjects participated to the study.
Who may be able to join
- Subjects with COPD, according to GOLD criteria (smokers and never smokers). Moreover, inhaled short-acting β2-agonists were stopped at least 8h before the test and inhaled long-acting β2-agonist were stopped at least 48h before the test.
- Healthy control subjects : never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms.
Who cannot join
- COPD patients were excluded from the study if they had an exacerbation, a respiratory tract infection or if they used a systemic form of corticosteroid preparation (oral or intravenous injection therapy) or antibiotics within the two months prior to the study entry. Patients with other respiratory disorder like pneumonia, pulmonary emboli, congestive heart failure, lung cancer or tuberculosis were also excluded.
About this study
Official title: Airway Inflammatory Profile and Clinical Presentation of COPD: A Comparison Between Never Smokers and Smokers
The aim of this study was to investigate the airway inflammatory profile and the clinical presentation of chronic obstructive pulmonary disease (COPD) in never smokers compared to smokers with COPD.
Read the detailed description
40 COPD patients (21 smokers and 19 never smokers) and 28 healthy never smokers were included in the present study. Information about respiratory symptoms and comorbidities were collected. Subjects underwent pulmonary function tests and COPD was defined according to Global Initiative for Chronic Obstructive lung Disease spirometric criteria. Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α)). The Mann-Whitney U and the χ2 tests were used for results comparisons. Correlations between symptoms, spirometric parameters, cytokines levels, inflammatory cells and risk factors of COPD were examined with Spearman's rank correlation test.
- Conditions
- COPD, Airway Obstruction, Inflammation
- Being tested
- Analysis of induced sputum, Lung Function test, Enzyme-linked Immunosorbent Assay
- Keywords
- COPD, smoking, induced sputum, clinical features
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Airway Obstruction, Inflammation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of induced sputumDiagnostic test
Induced sputum was collected and analysed in the three arms (Healthy subjects, Never smokers with COPD and smokers with COPD) The volume of the sputum sample, was treated with an equal volume of 0.1% dithiothreitol. The samples were then vortexed and placed in a shaking water bath at 37°C for 15 min to ensure complete homogeneisation. The suspensions were centrifuged at 400× g and the sputum supernatant stored at -80°C until cytokines analysis. The cell pellet was resuspended in 0.5% bovine serum albumin in phosphate buffered saline and cytospin were made by putting 100 µL of the cell suspension in the funnels.
Slides for differential cell counts were stained with May-Grünwald Giemsa.
Lung Function testDiagnostic test
Also called spirometry
All the subjects underwent pulmonary function tests (Healthy subjects, Never smokers with COPD and smokers with COPD).
Pulmonary function parameters were measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the ATS criteria (American Thoracic Society). Reversibility test was performed 15 min after inhalation of 400 µg of Salbutamol (Ventolin, GlaxoSmithKline, Middlesex, UK). All spirometry data were graded for quality and only tests that met high quality scores were used for the final analysis.
Enzyme-linked Immunosorbent AssayDiagnostic test
Also called ELISA
IL-8 and TNF-α were measured in the sputum supernatant of all the subjects (Healthy subjects, Never smokers with COPD and smokers with COPD).
Commercially available kits were used to detect IL-8 (Human IL-8 Immuno-Biological Laboratories ELISA Kit) and TNF-α (Human TNF-alpha Sigma-Aldrich ELISA Kit) concentrations in the sputum supernatants. The absorbance was measured at 450 nm. The lower limits detection were 2 pg/mL for IL-8 and 5 pg/mL for TNF-α. The intra assay coefficients of variability were 8.7% for IL-8 and 7.7% for TNF- α.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy non-smoking subjects were never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms.
Information about respiratory symptoms and comorbidities were collected. Healthy subjects underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). Receives: Diagnostic Test: Analysis of induced sputum; Diagnostic Test: Lung Function test; Diagnostic Test: Enzyme-linked Immunosorbent Assay | |
| COPD Never smokers | Never smokers referred to subjects who had never smoked Airflow limitation in COPD was defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio <70% and FEV1 reversibility of <12% and 200 mL from baseline values after inhalation of 400 µg of Salbutamol.
Information about respiratory symptoms and comorbidities were collected. Never smoking subjects with COPD underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). Receives: Diagnostic Test: Analysis of induced sputum; Diagnostic Test: Lung Function test; Diagnostic Test: Enzyme-linked Immunosorbent Assay | |
| COPD Smokers | Smokers were defined as persons who had smoked > 20 packs of cigarettes in a lifetime and who continue smoking every day.
Airflow limitation in COPD was defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio <70% and FEV1 reversibility of <12% and 200 mL from baseline values after inhalation of 400 µg of Salbutamol.
Information about respiratory symptoms and comorbidities were collected. Smoking subjects with COPD underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). Receives: Diagnostic Test: Analysis of induced sputum; Diagnostic Test: Lung Function test; Diagnostic Test: Enzyme-linked Immunosorbent Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight measurement
Weight was measured in kilograms for all the participants.
Measured: 6 months
Height measurement
Height was measured in meters for all the participants.
Measured: 6 months
Forced vital capacity (FVC)
FVC was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
Measured: 6 months
Forced expiratory volume in one second (FEV1)
FEV1 was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
Measured: 6 months
Sputum induction and collection
Sputum induction was conducted by inhalation of nebulised sterile hypertonic saline solution followed by coughing and expectoration of airway secretions. For nebulisation, an ultrasound nebulizer was used for 5-20 min to provide an adequate amount of sample. The subject is asked to cough and expectorate at 5 min intervals.
Measured: 6 months
Secondary outcomes (4)
BMI determination
Weight and height values were combined to report BMI in kg/m2
Measured: 6 months
Tiffeneau ratio (FEV1/FVC)
The calculation of FEV1/FVC allows the identification of obstructive ventilatory defect. A FEV1/FVC < 70 % where FEV1 is reduced more than FVC signifies an obstructive defect.
Measured: 6 months
Sputum cell counts
Four hundred non-squamous cells were counted by two technicians and the mean of the two scores was expressed as percentage of the total cell count. Sputum samples containing >20% of squamous cells and/or with cell viability <70% were excluded from analysis.
Measured: 1 month
Sputum supernatant analyses
IL-8 and TNF-α sputum supernatant concentrations were measured in the sputum supernatant of the three studied groups using ELISA test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study startSep 2013
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Scientific Research, Tunisia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Myriam Denguezli, Ministry of Scientific Research, Tunisia
- Investigators
- Zouhair Tabka, MD PhD, Study director, Faculty of Medicine of SousseAmina Mrizak, MSc, Principal investigator, Faculty of Medicine of Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274791
- Sponsor's protocol ID
- COPDNS
- Status last verified
- Sep 2017
- First submitted
- 24 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results will be shared in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Inflammatory Profile and Clinical Presentation of COPD: A Comparison Between Never Smokers and Smokers
- ClinicalTrials.gov ID
- NCT03274791
- Acronym / sponsor ID
- COPDNS
- Conditions
- COPD, Airway Obstruction, Inflammation
- Keywords
- COPD, smoking, induced sputum, clinical features
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ministry of Scientific Research, TunisiaOther government
- Study start
- Sep 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 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.
The aim of this study was to investigate the airway inflammatory profile and the clinical presentation of chronic obstructive pulmonary disease (COPD) in never smokers compared to smokers with COPD.
Detailed description
40 COPD patients (21 smokers and 19 never smokers) and 28 healthy never smokers were included in the present study. Information about respiratory symptoms and comorbidities were collected. Subjects underwent pulmonary function tests and COPD was defined according to Global Initiative for Chronic Obstructive lung Disease spirometric criteria. Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α)). The Mann-Whitney U and the χ2 tests were used for results comparisons. Correlations between symptoms, spirometric parameters, cytokines levels, inflammatory cells and risk factors of COPD were examined with Spearman's rank correlation test.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Diagnostic Test: Analysis of induced sputum, Diagnostic Test: Lung Function test, Diagnostic Test: Enzyme-linked Immunosorbent AssayHealthy non-smoking subjects were never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms. Information about respiratory symptoms and comorbidities were collected. Healthy subjects underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). |
| COPD Never smokers | – | Diagnostic Test: Analysis of induced sputum, Diagnostic Test: Lung Function test, Diagnostic Test: Enzyme-linked Immunosorbent AssayNever smokers referred to subjects who had never smoked Airflow limitation in COPD was defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio <70% and FEV1 reversibility of <12% and 200 mL from baseline values after inhalation of 400 µg of Salbutamol. Information about respiratory symptoms and comorbidities were collected. Never smoking subjects with COPD underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). |
| COPD Smokers | – | Diagnostic Test: Analysis of induced sputum, Diagnostic Test: Lung Function test, Diagnostic Test: Enzyme-linked Immunosorbent AssaySmokers were defined as persons who had smoked > 20 packs of cigarettes in a lifetime and who continue smoking every day. Airflow limitation in COPD was defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio <70% and FEV1 reversibility of <12% and 200 mL from baseline values after inhalation of 400 µg of Salbutamol. Information about respiratory symptoms and comorbidities were collected. Smoking subjects with COPD underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from the department of physiology and functional explorations of Sousse University Hospital. 40 subjects with COPD, according to GOLD criteria (21 current smokers and 19 never smokers) and 28 healthy control subjects participated to the study.
Key inclusion criteria (2 listed)
- Subjects with COPD, according to GOLD criteria (smokers and never smokers). Moreover, inhaled short-acting β2-agonists were stopped at least 8h before the test and inhaled long-acting β2-agonist were stopped at least 48h before the test.
- Healthy control subjects : never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms.
Key exclusion criteria (1 listed)
- COPD patients were excluded from the study if they had an exacerbation, a respiratory tract infection or if they used a systemic form of corticosteroid preparation (oral or intravenous injection therapy) or antibiotics within the two months prior to the study entry. Patients with other respiratory disorder like pneumonia, pulmonary emboli, congestive heart failure, lung cancer or tuberculosis were also excluded.
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 |
|---|---|---|
| Analysis of induced sputumInduced sputum was collected and analysed in the three arms (Healthy subjects, Never smokers with COPD and smokers with COPD) The volume of the sputum sample, was treated with an equal volume of 0.1% dithiothreitol. The samples were then vortexed and placed in a shaking water bath at 37°C for 15 min to ensure complete homogeneisation. The suspensions were centrifuged at 400× g and the sputum supernatant stored at -80°C until cytokines analysis. The cell pellet was resuspended in 0.5% bovine serum albumin in phosphate buffered saline and cytospin were made by putting 100 µL of the cell suspension in the funnels. Slides for differential cell counts were stained with May-Grünwald Giemsa. | Diagnostic test | COPD Never smokers, COPD Smokers, Healthy subjects |
| Lung Function testAlso: spirometryAll the subjects underwent pulmonary function tests (Healthy subjects, Never smokers with COPD and smokers with COPD). Pulmonary function parameters were measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the ATS criteria (American Thoracic Society). Reversibility test was performed 15 min after inhalation of 400 µg of Salbutamol (Ventolin, GlaxoSmithKline, Middlesex, UK). All spirometry data were graded for quality and only tests that met high quality scores were used for the final analysis. | Diagnostic test | COPD Never smokers, COPD Smokers, Healthy subjects |
| Enzyme-linked Immunosorbent AssayAlso: ELISAIL-8 and TNF-α were measured in the sputum supernatant of all the subjects (Healthy subjects, Never smokers with COPD and smokers with COPD). Commercially available kits were used to detect IL-8 (Human IL-8 Immuno-Biological Laboratories ELISA Kit) and TNF-α (Human TNF-alpha Sigma-Aldrich ELISA Kit) concentrations in the sputum supernatants. The absorbance was measured at 450 nm. The lower limits detection were 2 pg/mL for IL-8 and 5 pg/mL for TNF-α. The intra assay coefficients of variability were 8.7% for IL-8 and 7.7% for TNF- α. | Diagnostic test | COPD Never smokers, COPD Smokers, Healthy subjects |
Primary outcome
Weight measurement
Time frame: 6 months
Weight was measured in kilograms for all the participants.
Height measurement
Time frame: 6 months
Height was measured in meters for all the participants.
Forced vital capacity (FVC)
Time frame: 6 months
FVC was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
Forced expiratory volume in one second (FEV1)
Time frame: 6 months
FEV1 was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
Sputum induction and collection
Time frame: 6 months
Sputum induction was conducted by inhalation of nebulised sterile hypertonic saline solution followed by coughing and expectoration of airway secretions. For nebulisation, an ultrasound nebulizer was used for 5-20 min to provide an adequate amount of sample. The subject is asked to cough and expectorate at 5 min intervals.
4 secondary outcomes
BMI determination
Time frame: 6 months
Tiffeneau ratio (FEV1/FVC)
Time frame: 6 months
Sputum cell counts
Time frame: 1 month
Sputum supernatant analyses
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: Yes. All IPD that underlie results will be shared in a publication
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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.
Zouhair Tabka, MD PhD study director
Faculty of Medicine of Sousse
Amina Mrizak, MSc principal investigator
Faculty of Medicine of Sousse
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Airway Obstruction, run by Ministry of Scientific Research, Tunisia.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight measurement (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2017.