Chronic Obstructive Pulmonary DiseaseNCT03432026
Phenotypes of COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Assiut University.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) has been defined by international guidelines as a common preventable and treatable disease characterized by persistent air flow limitation and respiratory symptoms caused by exposure to gases or noxious particles. COPD is a major cause of morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- High resolution computed tomography scan of the chest.
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Non smoker COPD stable patients
Who may be able to join
- Non-smoker COPD patients.
- Stable COPD patients (≥4 weeks without exacerbation or worsening of any relevant comorbidity).
Who cannot join
- Patients with COPD exacerbation.
- Patients with associated obstructive sleep apnea.
- Patients with associated interstitial lung disease.
- patients with associated cardiac problems.
- Patients with associated bronchiaectasis.
About this study
Official title: Chronic Obstructive Pulmonary Disease Phenotypes in Non-Smokers
Chronic Obstructive Pulmonary Disease (COPD) has been defined by international guidelines as a common preventable and treatable disease characterized by persistent air flow limitation and respiratory symptoms caused by exposure to gases or noxious particles.
COPD is a major cause of morbidity and mortality worldwide. It is predicted to become the third leading cause of death and the fifth leading cause of disability by the year 2020.
Read the detailed description
Although the disease has been greatly associated with tobacco smoking, non- smokers can also have COPD, and the burden of COPD in non-smokers is also higher than previously believed especially in developing countries. Exposure to gases, environmental pollution, respiratory infection, noxious particles, passive smoking, and indoor air pollution is the main cause of COPD in non smokers.
COPD over the years has been classified into two phenotypes; chronic bronchitis or classic emphysema.However, The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines over the last few years have stopped emphasizing the categorization of chronic obstructive pulmonary disease (COPD) into only emphysema or chronic bronchitis
Clear examples of COPD phenotypes in smokers have been described in different Researches,such as emphysema, chronic bronchitis, frequent exacerbators and the asthma_copd overlap.,but there is alack of information about COPD phenotypes in non-smokers, So, there is a continuous need for research into groups of non smoking patients.
Therefore, the aim of this study is to describe the phenotypes of COPD, their risk factors, Clinical and functional assessment and the prognosis of each COPD phenotype in non-smoking patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- High resolution computed tomography scan of the chest.
- 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.
High resolution computed tomography scan of the chest.Device
High resolution computed tomography scan of the chest \& pulmonary function tests will be done for every patient to classify them.
| Study group | Role | What they receive |
|---|---|---|
| Non-smoker COPD patients | stable non-smoker COPD patients diagnosed by a previous spiromtery to have FEV1/FVC less than 70 Receives: Device: High resolution computed tomography scan of the chest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of risk factors of COPD in non smokers.
Complete medical history will be taken for each patient to detect risk factors of COPD.
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2021 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C F Shamshon, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432026
- Sponsor's protocol ID
- COPD
- Status last verified
- Jun 2018
- First submitted
- 22 Jan 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sharma BB, Singh V. Nonsmoker COPD: Is it a reality? Lung India. 2017 Mar-Apr;34(2):117-119. doi: 10.4103/lungindia.lungindia_56_17. No abstract available.
PubMed 28360456Mohan A, Sharma M, Uniyal A, Borah R, Luthra K, Pandey RM, Madan K, Hadda V, Guleria R. Variability in proteinase-antiproteinase balance, nutritional status, and quality of life in stable chronic obstructive pulmonary disease due to tobacco and nontobacco etiology. Lung India. 2016 Nov-Dec;33(6):605-610. doi: 10.4103/0970-2113.192859.
PubMed 27890988
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease Phenotypes in Non-Smokers
- ClinicalTrials.gov ID
- NCT03432026
- Acronym / sponsor ID
- COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 13 Feb 2018 (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.
Chronic Obstructive Pulmonary Disease (COPD) has been defined by international guidelines as a common preventable and treatable disease characterized by persistent air flow limitation and respiratory symptoms caused by exposure to gases or noxious particles.
COPD is a major cause of morbidity and mortality worldwide. It is predicted to become the third leading cause of death and the fifth leading cause of disability by the year 2020.
Detailed description
Although the disease has been greatly associated with tobacco smoking, non- smokers can also have COPD, and the burden of COPD in non-smokers is also higher than previously believed especially in developing countries. Exposure to gases, environmental pollution, respiratory infection, noxious particles, passive smoking, and indoor air pollution is the main cause of COPD in non smokers.
COPD over the years has been classified into two phenotypes; chronic bronchitis or classic emphysema.However, The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines over the last few years have stopped emphasizing the categorization of chronic obstructive pulmonary disease (COPD) into only emphysema or chronic bronchitis
Clear examples of COPD phenotypes in smokers have been described in different Researches,such as emphysema, chronic bronchitis, frequent exacerbators and the asthma_copd overlap.,but there is alack of information about COPD phenotypes in non-smokers, So, there is a continuous need for research into groups of non smoking patients.
Therefore, the aim of this study is to describe the phenotypes of COPD, their risk factors, Clinical and functional assessment and the prognosis of each COPD phenotype in non-smoking patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-smoker COPD patients | – | Device: High resolution computed tomography scan of the chest.stable non-smoker COPD patients diagnosed by a previous spiromtery to have FEV1/FVC less than 70 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Non smoker COPD stable patients
Key inclusion criteria (2 listed)
- Non-smoker COPD patients.
- Stable COPD patients (≥4 weeks without exacerbation or worsening of any relevant comorbidity).
Key exclusion criteria (5 listed)
- Patients with COPD exacerbation.
- Patients with associated obstructive sleep apnea.
- Patients with associated interstitial lung disease.
- patients with associated cardiac problems.
- Patients with associated bronchiaectasis.
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 |
|---|---|---|
| High resolution computed tomography scan of the chest.High resolution computed tomography scan of the chest \& pulmonary function tests will be done for every patient to classify them. | Device | Non-smoker COPD patients |
Primary outcome
Rate of risk factors of COPD in non smokers.
Time frame: 48 hour
Complete medical history will be taken for each patient to detect risk factors of COPD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Background: PubMed 28360456Sharma BB, Singh V. Nonsmoker COPD: Is it a reality? Lung India. 2017 Mar-Apr;34(2):117-119. doi: 10.4103/lungindia.lungindia_56_17. No abstract available.
- Background: PubMed 27890988Mohan A, Sharma M, Uniyal A, Borah R, Luthra K, Pandey RM, Madan K, Hadda V, Guleria R. Variability in proteinase-antiproteinase balance, nutritional status, and quality of life in stable chronic obstructive pulmonary disease due to tobacco and nontobacco etiology. Lung India. 2016 Nov-Dec;33(6):605-610. doi: 10.4103/0970-2113.192859.
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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?
An observational study of 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 2 inclusion and 5 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 27 Jun 2018. 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?
Rate of risk factors of COPD in non smokers. (time frame: 48 hour). 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 NCT03432026, 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 27 Jun 2018.