Chronic Obstructive Pulmonary DiseaseNCT05826613
Respiratory Registry for Lung Health: a Prospective, Observational Study on Adult Patients With Asthma or COPD
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 4 sites in Italy.
Trial summary
The database will contain a wide range of demographic, clinical, radiological, laboratory, functional, microbiological, treatment, and clinical outcomes data on adults with chronic obstructive pulmonary disease (COPD) and asthma enrolled during stable state with annual follow-up (either one or two-year follow up). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma
- How many people
- 500 participants
- Where
- 4 sitesItaly
- Study dates
- 10 Sep 2019to 31 May 2024
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or Female aged > 18 years with clinical Diagnosis of either COPD or Asthma. Asthma and COPD will be defined according to the latest international guidelines (https://goldcopd.org and https://ginasthma.org/2018-gina-report-global-strategy-for-asthmamanagement-and-prevention/)
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Male or Female aged > 18 years.
- Clinical Diagnosis of either COPD or Asthma
Who cannot join
- No specific exclusion criteria will be applied to the registry in order to be as adherent as possible to the real-life population
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Ospedale Papa Giovanni XXIII
Bergamo
Fabiano Di Marco, Prof, 0281843036, fabiano.dimarco@unimi.it
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Maura Spotti, PHD, 0255036403, maura.spotti@policlinico.mi.it
- Recruiting
Ospedale Luigi Sacco, Milano
Milan
Pier Achille Santus, Prof, 0239041, pierachille.santus@unimi.it
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Luca Richeldi, Prof, 0630156202, luca.richeldi@policlinicogemelli.it
About this study
Official title: Respiratory Registry for Lung Health: a Prospective, Observational Study on Adult Patients With Asthma or COPD for the Identification of Genetic Biomarkers Related to the Chronic Obstructive Lung Diseases
The database will contain a wide range of demographic, clinical, radiological, laboratory, functional, microbiological, treatment, and clinical outcomes data on adults with chronic obstructive pulmonary disease (COPD) and asthma enrolled during stable state with annual follow-up (either one or two-year follow up).
Primary Objective: To collect clinical (including quality of life measurements), laboratory (including non-invasive measurement of biomarkers), microbiological, radiological, functional, treatment variables and clinical outcomes, in adult patients with either asthma or COPD during stable state.
Secondary Objectives: To identify genetic and other omics patterns to develop phenotype handprints for adults with either asthma or COPD. To characterize the airways microbiome in stable patients with either asthma or COPD and identify correlation with clinical phenotypes and/or endotypes.
Read the detailed description
Currently, the World Health Organization estimates that chronic obstructive pulmonary disease (COPD) affects 65 million individuals worldwide and asthma affects 235 million. (World Health Organization. Chronic respiratory diseases. URL: http://www.who.int/respiratory/en/). In 2015, mortality from COPD exceeded 3 million deaths, while mortality from asthma included approximately 400 000 deaths (1). Unquestionably, COPD and asthma pose a significant global burden to which many of our healthcare resources are devoted.
COPD pathology is thought to be primarily due to inflammation. However, Eapen et al.(2) found a reduction in total cellularity in both large (endobronchial biopsies) and small airways (resected lung tissues) with a corresponding reduction in key innate inflammatory cell populations in mild-moderate COPD patients. Colonizing microbes were also found to contribute to pathogenesis, with a possible mechanism through perpetuation of negative immune responses over time (3).
Although cigarette smoking is the most significant risk factor, only a fraction of smokers develops COPD, so genetic associations should also be considered when assessing potential risk factors. The knowledge of the pathogenic mechanisms and genetic bases of respiratory diseases is fundamental for the correct setting of pharmacological and non-pharmacological management. If we consider the main respiratory diseases (COPD, asthma, idiopathic pulmonary fibrosis) but also the so-called rare diseases (e.g. cystic fibrosis), it is evident that both the expression of the disease and the response to treatment are very different among patients. Recent evidences have shown that these responses are related to different genetic models. Decision-making in medical care for decades has often relied on a "one-size-fits-all" approach that applies mean-effect-size results from studies to individual patients. The goal of precision medicine, in contrast, is to allow for more accurate treatment and prevention, decisions based on matching a patient's exposure, lifestyle and biological profile to that of similar patients with measured outcomes. It could be reasonable to hypothesize that mutations in genes which are involved in other respiratory diseases (such as primary ciliary dyskinesia or cystic fibrosis) might be present also in patients with either asthma or COPD. These mutations might alter the function of specific proteins (such as the cystic fibrosis transmembrane conductance regulator protein) and, thus, contribute to the pathophysiology of asthma or COPD. The goal of many "-omics" studies thus far has been to build a knowledgebase of omic variation using single-technology approaches that will help enable precision medicine by providing reference data to identify groups of individuals who share various attributes. In addition to collecting omics data, the application of sophisticated algorithms and use of extensive computational resources to integrate datasets are required to fully characterize diverse patients. The Respiratory Registry project aims to describe the epidemiology of chronic respiratory diseases, including COPD and Asthma, in the cities of Milan, Bergamo and Rome, to define different clinical phenotypes of these diseases, the relative genetic models and the endotypic expression, and then propose new therapeutic approaches, through the implementation of a clinical registry and an enlarged genetic study.
A database of respiratory diseases would have many important functions including but not limited to: 1) Analysis and evaluation of current standard operating procedures in different centres in Milan, Bergamo and Rome in order to compare them with recommendations of the international guidelines and with those used in other countries; 2) Analysis and assessment of differences in the management of adult patients by various professionals in the different centres in order to identify any area of improvement and/or the need to perform further clinical or translation studies; 3) Analysis and evaluation of several factors of disease severity (e.g., recurrence, hospitalization, mortality) that require large amounts of data not obtainable from monocentric studies.
The database will contain a wide range of demographic, clinical, radiological, laboratory, functional, microbiological, treatment, and clinical outcomes data on adults with COPD and asthma enrolled during stable state with annual follow-up (either one or two-year follow up). The database will be developed at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano and managed by the University Pneumology Unit of this hospital (Promoter of the study). Other University Pneumology Units will be involved, including those from the ASST Santi Paolo e Carlo Hospital in Milan, the ASST Fatebenefratelli-Sacco Hospital in Milan, the IRCCS Policlinico San Donato Hospital in San Donato, Milan, the Papa Giovanni XXIII Hospital in Bergamo and the Respiratory Unit of the Policlinico Gemelli in Rome. Data will be recorded using a case report form (CRF), incorporating all the variables related to the obstructive respiratory diseases identified as relevant for the purpose of this study: COPD and asthma. Study participants will also enter patient follow-up data on an annual basis to provide longitudinal data regarding clinical and therapeutic changes, as well as clinical outcomes. The total study duration will be 3 years, including 2 years for enrollment and at least 1 year of follow-up.
The study will be conducted in accordance with the principles of Good Clinical Practice (GCP). A favourable ethical opinion will be obtained first (as coordinating centre) by the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan and then by each partner site from the appropriate research ethics committee. Furthermore, any other necessary approval required by partner site will be obtained prior to the commencement of the study at that site. All patients must provide written consent to participate in the registry. It is the responsibility of the investigator at each centre to obtain the appropriate local approvals. This prospective observational study will provide important data for the personalised management of obstructive lung diseases. No risk for the patient is foreseen. Informed consent for participation in the study, sample collection and omic analyses will be mandatory.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adults with COPD and asthma | Male or female aged >18 years with clinical diagnosis of either COPD or asthma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auscultation of the chest
A respiratory physical examination, according to the usual care, will be performed and include an assessment of the following: presence of wheeze (yes or no), presence of stridor (yes or no), presence of crackles (yes or no).
Measured: 1 year
Presence of dyspnoea (mMRC scale)
A respiratory physical examination, according to the usual care, will be performed and include an assessment of the presence of dyspnoea. The measurement that will be used to assess this outcome measure is mMRC scale.
Measured: 1 year
Forced vital capacity (FVC)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: FVC (reported in l)
Measured: 1 year
Forced Expiratory Volume in the 1st second (FEV1)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: FEV1 (reported in l)
Measured: 1 year
Peak expiratory flow (PEF)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: PEF(reported in l/min)
Measured: 1 year
Vital capacity (VC)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: VC (reported in l)
Measured: 1 year
Total Lung Capacity (TLC)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: TLC (reported in l)
Measured: 1 year
Residual Volume (RV)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: RV (reported in l)
Measured: 1 year
specific airway resistance (SRaw)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: sRaw (reported in kPa)
Measured: 1 year
specific airway conductance (SGaw)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: sGaw (reported in kPa)
Measured: 1 year
Diffusing Capacity Of The Lungs For Carbon Monoxide (DLCO)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: DLCO.
Measured: 1 year
fraction of exhaled NO (FENO)
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: FeNO.
Measured: 1 year
Blood pulse
The following vital signs will be recorded according to usual care of COPD and Asthma patient: Pulse (recorded in beat per minute)
Measured: 1 year
Blood pressure
The following vital signs will be recorded according to usual care of COPD and Asthma patient: blood pressure (reported in mmHg)
Measured: 1 year
body temperature
The following vital signs will be recorded according to usual care of COPD and Asthma patient: Body temperature (reported in °C)
Measured: 1 year
respiratory rate
The following vital signs will be recorded according to usual care of COPD and Asthma patient: Respiratory Rate (reported in breath per minute)
Measured: 1 year
St. George Respiratory Questionnaire
Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.
Measured: 1 year
Asthma control test (ACT)
Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.
Measured: 1 year
COPD assessment test (CAT)
Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.
Measured: 1 year
Secondary outcomes (1)
Collection of biological samples
The subject's consent to participate in the genetic research components of the study is not mandatory. Two sputum samples, a total of 20 cc of Bronchoalveolar Lavage (BAL), one sample of bronchoaspirate, one slice of lung biopsies, a total of 15 cc of blood, one sample of stool and a total of 15 cc of urine may be collected during routine clinical practice (at the enrolment visit) on stable state. If for any reason the sample will not be drawn at the inclusion visit, it may be taken at any visit until the last study visit. Samples' collection will be performed once per subject during the study and stored locally at each study site and then sent to the Biobank of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan for storage or to the respiratory Infections Laboratory of the analysis Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan for analysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 Sep 2019
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Blasi, Prof., Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826613
- Sponsor's protocol ID
- ESR-18-13818
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16.
PubMed 28822787Eapen MS, McAlinden K, Tan D, Weston S, Ward C, Muller HK, Walters EH, Sohal SS. Profiling cellular and inflammatory changes in the airway wall of mild to moderate COPD. Respirology. 2017 Aug;22(6):1125-1132. doi: 10.1111/resp.13021. Epub 2017 Mar 22.
PubMed 28326668Leung JM, Tiew PY, Mac Aogain M, Budden KF, Yong VF, Thomas SS, Pethe K, Hansbro PM, Chotirmall SH. The role of acute and chronic respiratory colonization and infections in the pathogenesis of COPD. Respirology. 2017 May;22(4):634-650. doi: 10.1111/resp.13032. Epub 2017 Mar 25.
PubMed 28342288
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Registry for Lung Health: a Prospective, Observational Study on Adult Patients With Asthma or COPD for the Identification of Genetic Biomarkers Related to the Chronic Obstructive Lung Diseases
- ClinicalTrials.gov ID
- NCT05826613
- Acronym / sponsor ID
- ESR-18-13818
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 24 Apr 2023 (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 database will contain a wide range of demographic, clinical, radiological, laboratory, functional, microbiological, treatment, and clinical outcomes data on adults with chronic obstructive pulmonary disease (COPD) and asthma enrolled during stable state with annual follow-up (either one or two-year follow up).
Primary Objective: To collect clinical (including quality of life measurements), laboratory (including non-invasive measurement of biomarkers), microbiological, radiological, functional, treatment variables and clinical outcomes, in adult patients with either asthma or COPD during stable state.
Secondary Objectives: To identify genetic and other omics patterns to develop phenotype handprints for adults with either asthma or COPD. To characterize the airways microbiome in stable patients with either asthma or COPD and identify correlation with clinical phenotypes and/or endotypes.
Detailed description
Currently, the World Health Organization estimates that chronic obstructive pulmonary disease (COPD) affects 65 million individuals worldwide and asthma affects 235 million. (World Health Organization. Chronic respiratory diseases. URL: http://www.who.int/respiratory/en/). In 2015, mortality from COPD exceeded 3 million deaths, while mortality from asthma included approximately 400 000 deaths (1). Unquestionably, COPD and asthma pose a significant global burden to which many of our healthcare resources are devoted.
COPD pathology is thought to be primarily due to inflammation. However, Eapen et al.(2) found a reduction in total cellularity in both large (endobronchial biopsies) and small airways (resected lung tissues) with a corresponding reduction in key innate inflammatory cell populations in mild-moderate COPD patients. Colonizing microbes were also found to contribute to pathogenesis, with a possible mechanism through perpetuation of negative immune responses over time (3).
Although cigarette smoking is the most significant risk factor, only a fraction of smokers develops COPD, so genetic associations should also be considered when assessing potential risk factors. The knowledge of the pathogenic mechanisms and genetic bases of respiratory diseases is fundamental for the correct setting of pharmacological and non-pharmacological management. If we consider the main respiratory diseases (COPD, asthma, idiopathic pulmonary fibrosis) but also the so-called rare diseases (e.g. cystic fibrosis), it is evident that both the expression of the disease and the response to treatment are very different among patients. Recent evidences have shown that these responses are related to different genetic models. Decision-making in medical care for decades has often relied on a "one-size-fits-all" approach that applies mean-effect-size results from studies to individual patients. The goal of precision medicine, in contrast, is to allow for more accurate treatment and prevention, decisions based on matching a patient's exposure, lifestyle and biological profile to that of similar patients with measured outcomes. It could be reasonable to hypothesize that mutations in genes which are involved in other respiratory diseases (such as primary ciliary dyskinesia or cystic fibrosis) might be present also in patients with either asthma or COPD. These mutations might alter the function of specific proteins (such as the cystic fibrosis transmembrane conductance regulator protein) and, thus, contribute to the pathophysiology of asthma or COPD. The goal of many "-omics" studies thus far has been to build a knowledgebase of omic variation using single-technology approaches that will help enable precision medicine by providing reference data to identify groups of individuals who share various attributes. In addition to collecting omics data, the application of sophisticated algorithms and use of extensive computational resources to integrate datasets are required to fully characterize diverse patients. The Respiratory Registry project aims to describe the epidemiology of chronic respiratory diseases, including COPD and Asthma, in the cities of Milan, Bergamo and Rome, to define different clinical phenotypes of these diseases, the relative genetic models and the endotypic expression, and then propose new therapeutic approaches, through the implementation of a clinical registry and an enlarged genetic study.
A database of respiratory diseases would have many important functions including but not limited to: 1) Analysis and evaluation of current standard operating procedures in different centres in Milan, Bergamo and Rome in order to compare them with recommendations of the international guidelines and with those used in other countries; 2) Analysis and assessment of differences in the management of adult patients by various professionals in the different centres in order to identify any area of improvement and/or the need to perform further clinical or translation studies; 3) Analysis and evaluation of several factors of disease severity (e.g., recurrence, hospitalization, mortality) that require large amounts of data not obtainable from monocentric studies.
The database will contain a wide range of demographic, clinical, radiological, laboratory, functional, microbiological, treatment, and clinical outcomes data on adults with COPD and asthma enrolled during stable state with annual follow-up (either one or two-year follow up). The database will be developed at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano and managed by the University Pneumology Unit of this hospital (Promoter of the study). Other University Pneumology Units will be involved, including those from the ASST Santi Paolo e Carlo Hospital in Milan, the ASST Fatebenefratelli-Sacco Hospital in Milan, the IRCCS Policlinico San Donato Hospital in San Donato, Milan, the Papa Giovanni XXIII Hospital in Bergamo and the Respiratory Unit of the Policlinico Gemelli in Rome. Data will be recorded using a case report form (CRF), incorporating all the variables related to the obstructive respiratory diseases identified as relevant for the purpose of this study: COPD and asthma. Study participants will also enter patient follow-up data on an annual basis to provide longitudinal data regarding clinical and therapeutic changes, as well as clinical outcomes. The total study duration will be 3 years, including 2 years for enrollment and at least 1 year of follow-up.
The study will be conducted in accordance with the principles of Good Clinical Practice (GCP). A favourable ethical opinion will be obtained first (as coordinating centre) by the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan and then by each partner site from the appropriate research ethics committee. Furthermore, any other necessary approval required by partner site will be obtained prior to the commencement of the study at that site. All patients must provide written consent to participate in the registry. It is the responsibility of the investigator at each centre to obtain the appropriate local approvals. This prospective observational study will provide important data for the personalised management of obstructive lung diseases. No risk for the patient is foreseen. Informed consent for participation in the study, sample collection and omic analyses will be mandatory.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults with COPD and asthma | – | –Male or female aged >18 years with clinical diagnosis of either COPD or asthma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or Female aged > 18 years with clinical Diagnosis of either COPD or Asthma. Asthma and COPD will be defined according to the latest international guidelines (https://goldcopd.org and https://ginasthma.org/2018-gina-report-global-strategy-for-asthmamanagement-and-prevention/)
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures.
- Male or Female aged > 18 years.
- Clinical Diagnosis of either COPD or Asthma
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be applied to the registry in order to be as adherent as possible to the real-life population
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
Auscultation of the chest
Time frame: 1 year
A respiratory physical examination, according to the usual care, will be performed and include an assessment of the following: presence of wheeze (yes or no), presence of stridor (yes or no), presence of crackles (yes or no).
Presence of dyspnoea (mMRC scale)
Time frame: 1 year
A respiratory physical examination, according to the usual care, will be performed and include an assessment of the presence of dyspnoea. The measurement that will be used to assess this outcome measure is mMRC scale.
Forced vital capacity (FVC)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: FVC (reported in l)
Forced Expiratory Volume in the 1st second (FEV1)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: FEV1 (reported in l)
Peak expiratory flow (PEF)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: PEF(reported in l/min)
Vital capacity (VC)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: VC (reported in l)
Total Lung Capacity (TLC)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: TLC (reported in l)
Residual Volume (RV)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: RV (reported in l)
specific airway resistance (SRaw)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: sRaw (reported in kPa)
specific airway conductance (SGaw)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: sGaw (reported in kPa)
Diffusing Capacity Of The Lungs For Carbon Monoxide (DLCO)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: DLCO.
fraction of exhaled NO (FENO)
Time frame: 1 year
A complete respiratory functional evaluation will be performed according to the usual care for COPD and Asthma patient. Pulmonary function testing will include: FeNO.
Blood pulse
Time frame: 1 year
The following vital signs will be recorded according to usual care of COPD and Asthma patient: Pulse (recorded in beat per minute)
Blood pressure
Time frame: 1 year
The following vital signs will be recorded according to usual care of COPD and Asthma patient: blood pressure (reported in mmHg)
body temperature
Time frame: 1 year
The following vital signs will be recorded according to usual care of COPD and Asthma patient: Body temperature (reported in °C)
respiratory rate
Time frame: 1 year
The following vital signs will be recorded according to usual care of COPD and Asthma patient: Respiratory Rate (reported in breath per minute)
St. George Respiratory Questionnaire
Time frame: 1 year
Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.
Asthma control test (ACT)
Time frame: 1 year
Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.
COPD assessment test (CAT)
Time frame: 1 year
Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.
1 secondary outcome
Collection of biological samples
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Background: PubMed 28822787GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16.
- Background: PubMed 28326668Eapen MS, McAlinden K, Tan D, Weston S, Ward C, Muller HK, Walters EH, Sohal SS. Profiling cellular and inflammatory changes in the airway wall of mild to moderate COPD. Respirology. 2017 Aug;22(6):1125-1132. doi: 10.1111/resp.13021. Epub 2017 Mar 22.
- Background: PubMed 28342288Leung JM, Tiew PY, Mac Aogain M, Budden KF, Yong VF, Thomas SS, Pethe K, Hansbro PM, Chotirmall SH. The role of acute and chronic respiratory colonization and infections in the pathogenesis of COPD. Respirology. 2017 May;22(4):634-650. doi: 10.1111/resp.13032. Epub 2017 Mar 25.
- Individual participant dataSharing planned: No
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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.
Francesco Blasi, Prof. principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4 sites 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 and Asthma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 4 sites in Italy.
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 3 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Blasi, Prof. (0250320627, francesco.blasi@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auscultation of the chest (time frame: 1 year). The study lists 19 primary outcomes in all. 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 NCT05826613, which also lists 3 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 24 Apr 2023.