CopdNCT04711629
Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease
A study testing Clinical Tests in people with Copd and Smoking, run by Izmir Katip Celebi University.
Trial summary
Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- What is being tested?
- Clinical Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2022
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoker COPD Patients who smoker
Who cannot join
- Not volunteer to participate the study
About this study
Official title: Clinical Characteristics of Chronic Obstructive Pulmonary Patients Who Continue to Smoke
Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want.
The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life.
Read the detailed description
The study was designed prospectively. Patients with COPD who apply to the pulmonary rehabilitation outpatient clinic will be included.
The data of patients with COPD who are eligible for PR and have been pre-evaluated will be scanned. Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale will be used in the study. Patients with COPD who smoke will constitute the study group, and those who quit smoking will constitute the control group.
- Being tested
- Clinical Tests
- Keywords
- copd, smoking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical TestsOther
Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale
| Study group | Role | What they receive |
|---|---|---|
| Smoker COPD | Experimental | Patients who continue to smoke Receives: Other: Clinical Tests |
| Ex-smoker COPD | Active comparator | Patients who quit smoking. Receives: Other: Clinical Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Six minutes walk test
Measured: 6 minutes
Secondary outcomes (6)
Respiratory Functions
Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).
Measured: 30 minutes
Dyspnea Sensation
Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath.
Measured: 20 minutes
Disease Specific Quality of Life
St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms.
Measured: 20 minutes
Anxiety
Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Measured: 20 minutes
Depression
Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Measured: 20 minutes
Body Mass Index
Body mass index is calculated by dividing body mass by the square of length in meters.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Smoker COPD Ex Smoker COPD
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711629
- Sponsor's protocol ID
- IKCU-INAZ
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Chronic Obstructive Pulmonary Patients Who Continue to Smoke
- ClinicalTrials.gov ID
- NCT04711629
- Acronym / sponsor ID
- IKCU-INAZ
- Keywords
- copd, smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Jan 2021 (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.
Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want.
The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life.
Detailed description
The study was designed prospectively. Patients with COPD who apply to the pulmonary rehabilitation outpatient clinic will be included.
The data of patients with COPD who are eligible for PR and have been pre-evaluated will be scanned. Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale will be used in the study. Patients with COPD who smoke will constitute the study group, and those who quit smoking will constitute the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Smoker COPD Ex Smoker COPD
| Arm | Type | Receives |
|---|---|---|
| Smoker COPD | Experimental | Other: Clinical TestsPatients who continue to smoke |
| Ex-smoker COPD | Active comparator | Other: Clinical TestsPatients who quit smoking. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoker COPD Patients who smoker
Key exclusion criteria (1 listed)
- Not volunteer to participate the study
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 |
|---|---|---|
| Clinical TestsRespiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale | Other | Ex-smoker COPD, Smoker COPD |
Primary outcome
Exercise Capacity
Time frame: 6 minutes
Six minutes walk test
6 secondary outcomes
Respiratory Functions
Time frame: 30 minutes
Dyspnea Sensation
Time frame: 20 minutes
Disease Specific Quality of Life
Time frame: 20 minutes
Anxiety
Time frame: 20 minutes
Depression
Time frame: 20 minutes
Body Mass Index
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Tests in people with Copd and Smoking, run by Izmir Katip Celebi 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 1 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: status not confirmed, as of the sponsor's last update on 15 Jan 2021. 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?
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?
Exercise Capacity (time frame: 6 minutes). 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 15 Jan 2021.