Chronic Obstructive Pulmonary DiseasePro-BPCONCT01713335
Proteasis Evaluation in COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2012to Apr 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stable COPD patients were recruited from pulmonary primary care of pulmonary division of CHRU of Tours. COPD with acute exacerbation were recruited from hospitalisation of pulmonary division of CHRU of Tours and intensive care unit of CHRU of Tours.
Who may be able to join
- Smoker with tobacco consumption of 20 pack/year
- Normal lung function tests
- Smoker with tobacco consumption of 20 pack/year
- FEV1/FVC<70% on lung function tests
- no hospitalisation for exacerbation during 3 months before inclusion
- Smoker with tobacco consumption of 20 pack/year
- worsening of pulmonary symptoms
- FEV1/FVC<70% on lung function tests could be obtain before or 3 months after exacerbation
Who cannot join
- diagnosis of lung disease during the study
- Asthma
- Lung cancer
- Pregnant and lactating women
- Asthma
- Lung cancer
Show all 10Show fewer
- Pregnant and lactating women
- Asthma
- Lung cancer
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be included: Healthy smoker subjects, stable COPD patients and COPD patients with acute exacerbation. Kallicrein levels in sputum will be compared in these groups.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Kallikrein level in sputum by ELISA
Measured: One sample at inclusion
Secondary outcomes (1)
Comparison between kallikrein level and clinical or functionnal parameters
Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score
Measured: All data will be identified at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study start18 Oct 2012
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laurent Guilleminault, MD, Principal investigator, Service de Pneumologie, CHRU Tours, Tours, FranceValérie Gissot, MD, Principal investigator, Centre d'Investigation Clinique, CHRU Tours, Tours, FranceAntoine Guillon, MD, Principal investigator, Service de Réanimation médicale, CHRU Tours, Tours, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713335
- Sponsor's protocol ID
- C11-56
- Other IDs
- 2012-A00885-38
- Acronym
- Pro-BPCO
- Status last verified
- Aug 2021
- First submitted
- 15 Oct 2012
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteasis Evaluation in COPD
- ClinicalTrials.gov ID
- NCT01713335
- Acronym / sponsor ID
- Pro-BPCO / C11-56
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 18 Oct 2012 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Oct 2012 (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.
The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be included: Healthy smoker subjects, stable COPD patients and COPD patients with acute exacerbation. Kallicrein levels in sputum will be compared in these groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stable COPD patients were recruited from pulmonary primary care of pulmonary division of CHRU of Tours. COPD with acute exacerbation were recruited from hospitalisation of pulmonary division of CHRU of Tours and intensive care unit of CHRU of Tours.
Key inclusion criteria (8 listed)
- Smoker with tobacco consumption of 20 pack/year
- Normal lung function tests
- Smoker with tobacco consumption of 20 pack/year
- FEV1/FVC<70% on lung function tests
- no hospitalisation for exacerbation during 3 months before inclusion
Key exclusion criteria (10 listed)
- diagnosis of lung disease during the study
- Asthma
- Lung cancer
- Pregnant and lactating women
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kallikrein level in sputum by ELISA
Time frame: One sample at inclusion
1 secondary outcome
Comparison between kallikrein level and clinical or functionnal parameters
Time frame: All data will be identified at inclusion
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 26 Aug 2021.
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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.
Laurent Guilleminault, MD principal investigator
Service de Pneumologie, CHRU Tours, Tours, France
Valérie Gissot, MD principal investigator
Centre d'Investigation Clinique, CHRU Tours, Tours, France
Antoine Guillon, MD principal investigator
Service de Réanimation médicale, CHRU Tours, Tours, France
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 Chronic Obstructive Pulmonary Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 8 inclusion and 10 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 26 Aug 2021. 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 France. 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?
Kallikrein level in sputum by ELISA (time frame: One sample at inclusion). 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 26 Aug 2021.