NCT05826613

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

April 24, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

March 14, 2023

Last Update Submit

April 12, 2023

Conditions

Chronic Obstructive Pulmonary DiseaseAsthma

Outcome Measures

Primary Outcomes (19)

  • 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).

    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.

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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.

    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.

    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)

    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)

    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)

    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)

    1 year

  • St. George Respiratory Questionnaire

    Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.

    1 year

  • Asthma control test (ACT)

    Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.

    1 year

  • COPD assessment test (CAT)

    Quality of life questionnaires will be collected, according to usual care of COPD and asthma patients.

    1 year

Secondary Outcomes (1)

  • Collection of biological samples

    1 year

Study Arms (1)

adults with COPD and asthma

Male or female aged \>18 years with clinical diagnosis of either COPD or asthma.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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/)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures.
  • Male or Female aged \> 18 years.
  • Clinical Diagnosis of either COPD or Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

RECRUITING

Ospedale Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Ospedale Luigi Sacco, Milano

Milan, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28822787BACKGROUND

  • Eapen 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.

    PMID: 28326668BACKGROUND

  • Leung 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.

    PMID: 28342288BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, serum, sputum, urine, stool, lung biopsies, bronchoaspirate and bronchoalveolar lavage specimens

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Francesco Blasi, Prof.

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Blasi, Prof.

CONTACT

0250320627francesco.blasi@unimi.it

Maura Spotti, PHD

CONTACT

0255036403maura.spotti@policlinico.mi.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 24, 2023

Study Start

September 10, 2019

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

April 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(4)