Pulmonary Disease, Chronic ObstructiveSA1PLGNCT02498938
The Association of SERPINA1 Gene Disturbance in Patients With Lung and Gum Disorders
An observational study of Pulmonary Disease, Chronic Obstructive and Generalized Chronic Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases. The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with COPD serve as a risk factor for developing periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Generalized Chronic Periodontitis
- What is being tested?
- SERPINA1 gene
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2015to Dec 2015
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients,both male and female aged between 30-70yrs with COPD nd chronic periodontitis
Who may be able to join
- Male and female patients aged between 30-70yrs diagnosed with COPD and chronic periodontitis who are willing to participate in the study.
Who cannot join
- Pateints with other systemic disorders
- patients not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of SERPINA1 Gene Polymorphisms in COPD as a Risk Factor for Periodontitis
Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases. The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with COPD serve as a risk factor for developing periodontitis.
Read the detailed description
periodontitis is a polymicrobial inflammatory disease caused by various modifiable and non-modifiable risk factors. the non-modifiable risk factors include genetic polymorphisms like the gene coding for alpha-1-antitrypsinase
COPD is a chronic inflammatory disease characterized by deterioration of lung function due to loss of elasticity of the lungs.
SERPINA1 gene product has a protective role on the connective tissue components of both lungs and gums.
Hence, this study tries to determine if the gene polymorphism in COPD serves as a risk factor for developing periodontitis.
- Being tested
- SERPINA1 gene
- Keywords
- Pulmonary disease,chronic obstructive,, generalized chronic periodontitis, SERPINA1 gene polymorphism
- 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.
SERPINA1 geneGenetic
Also called serine peptidase inhibitor, proteinase inhibitor
2ml blood sample collected from patients to extract DNA for assessment of SERPINA1 gene polymorphism
| Study group | Role | What they receive |
|---|---|---|
| SERPINA1 gene in COPD and periodontitis | patients aged between 30-70 yrs with COPD (satisfying Gold's criteria) and chronic periodontitis (>4mm pocket probing depth) Receives: Genetic: SERPINA1 gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
SERPINA1 gene polymorphism
of blood samples and running samples by PCR
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionDec 2015
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 Pulmonary Disease, Chronic ObstructiveStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Sneha Agarwal, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Dr. Sneha Agarwal, PG(perio), Principal investigator, Panineeya Mahavidyalaya institute of dental sciences and research centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498938
- Sponsor's protocol ID
- D149206031
- Acronym
- SA1PLG
- Status last verified
- Aug 2016
- First submitted
- 13 Jul 2015
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Scott DA, von Ahsen N, Palmer RM, Wilson RF. Analysis of two common alpha 1-antitrypsin deficiency alleles (PI*Z and PI*S) in subjects with periodontitis. J Clin Periodontol. 2002 Dec;29(12):1118-21. doi: 10.1034/j.1600-051x.2002.291212.x.
PubMed 12492914Travis J, Pike R, Imamura T, Potempa J. The role of proteolytic enzymes in the development of pulmonary emphysema and periodontal disease. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 2):S143-6. doi: 10.1164/ajrccm/150.6_Pt_2.S143.
PubMed 7952650
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SERPINA1 Gene Polymorphisms in COPD as a Risk Factor for Periodontitis
- ClinicalTrials.gov ID
- NCT02498938
- Acronym / sponsor ID
- SA1PLG / D149206031
- Keywords
- Pulmonary disease,chronic obstructive,, generalized chronic periodontitis, SERPINA1 gene polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 2015 (estimated)
- 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 and periodontitis are chronic inflammatory diseases. The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with COPD serve as a risk factor for developing periodontitis.
Detailed description
periodontitis is a polymicrobial inflammatory disease caused by various modifiable and non-modifiable risk factors. the non-modifiable risk factors include genetic polymorphisms like the gene coding for alpha-1-antitrypsinase
COPD is a chronic inflammatory disease characterized by deterioration of lung function due to loss of elasticity of the lungs.
SERPINA1 gene product has a protective role on the connective tissue components of both lungs and gums.
Hence, this study tries to determine if the gene polymorphism in COPD serves as a risk factor for developing periodontitis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SERPINA1 gene in COPD and periodontitis | – | Genetic: SERPINA1 genepatients aged between 30-70 yrs with COPD (satisfying Gold's criteria) and chronic periodontitis (>4mm pocket probing depth) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients,both male and female aged between 30-70yrs with COPD nd chronic periodontitis
Key inclusion criteria (1 listed)
- Male and female patients aged between 30-70yrs diagnosed with COPD and chronic periodontitis who are willing to participate in the study.
Key exclusion criteria (2 listed)
- Pateints with other systemic disorders
- patients not willing to participate in 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 |
|---|---|---|
| SERPINA1 geneAlso: serine peptidase inhibitor, proteinase inhibitor2ml blood sample collected from patients to extract DNA for assessment of SERPINA1 gene polymorphism | Genetic | SERPINA1 gene in COPD and periodontitis |
Primary outcome
SERPINA1 gene polymorphism
Time frame: 9 months
of blood samples and running samples by PCR
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 29 Aug 2016.
- Background: PubMed 12492914Scott DA, von Ahsen N, Palmer RM, Wilson RF. Analysis of two common alpha 1-antitrypsin deficiency alleles (PI*Z and PI*S) in subjects with periodontitis. J Clin Periodontol. 2002 Dec;29(12):1118-21. doi: 10.1034/j.1600-051x.2002.291212.x.
- Background: PubMed 7952650Travis J, Pike R, Imamura T, Potempa J. The role of proteolytic enzymes in the development of pulmonary emphysema and periodontal disease. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 2):S143-6. doi: 10.1164/ajrccm/150.6_Pt_2.S143.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Dr. Sneha Agarwal, PG(perio) principal investigator
Panineeya Mahavidyalaya institute of dental sciences and research centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Generalized Chronic Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
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 2 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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
SERPINA1 gene polymorphism (time frame: 9 months). 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 NCT02498938, 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 29 Aug 2016.