Chronic Obstructive Pulmonary DiseaseNCT04421742
The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and SAD in COPD Patients.
An observational study of Chronic Obstructive Pulmonary Disease, run by Alfredo Antonio Chetta at 1 site in Italy.
Trial summary
In patients with chronic obstructive pulmonary disease (COPD), small-airway dysfunction (SAD) is considered a key element and a functional consequence of the pathology. However, the exact role of SAD as a specific 'pharmacological target' is not yet fully known. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Beclomethasone Dipropionate/Formoterol Fumarate
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2017to 23 May 2019
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients of the outpatient clinic of the Respiratory Disease Unit of the University Hospital in Parma (Italy)
Who may be able to join
- a documented diagnosis of COPD defined according to the guidelines of the American Thoracic Society (ATS) / European Respiratory Society (ERS);
- smokers or former smokers with a smoking history of at least 10 pack / years;
- subjects with a post-bronchodilator forced expiratory volume at the 1st second (FEV1)/ forced vital capacity (FVC) ratio of < 0.7 and a FEV1 <50% pred;
- subjects with a high impact of the COPD on their health status (CAT≥10);
- clinical history of at least 1 moderate exacerbation / year;
- COPD patients being treated with BDP/FF NEXThaler® 100/6 μg in extra-fine formulation no more than 1 (one) week before enrollment.
Who cannot join
- an exacerbation in the four weeks prior to enrollment;
- other coexisting lung diseases (bronchial asthma, restrictive diseases or bronchiectasis) and severe co-morbidities associated with COPD, such as uncontrolled cardiovascular disease, pneumonia or cancer;
- pregnant patients;
- subjects unable to meet the criteria of acceptability and repeatability of pulmonary function tests, according to the ATS / ERS document
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Italy
Parma, 43125
About this study
Official title: The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and Dyspnea is Associated to the Improvement in Small Airway Dysfunction in COPD Patients. A Pilot Study (IOSCOPD20161102)
In patients with chronic obstructive pulmonary disease (COPD), small-airway dysfunction (SAD) is considered a key element and a functional consequence of the pathology. However, the exact role of SAD as a specific 'pharmacological target' is not yet fully known.
Objectives In an open-label prospective study, we aimed to ascertain whether an extra-fine formulation of Beclomethasone dipropionate/Formoterol fumarate (BDP/FF) NEXThaler® 100/6 μg b.i.d. can improve the impact of the disease on the quality of daily life of COPD patients, acting on SAD.
Methods We studied COPD patients with severe airflow obstruction and 1 moderate exacerbation in the previous year, being treated with BDP/FF NEXThaler® for 12 weeks. They underwent three visits, at the start of the treatment (V1), at 6th week (V2) and at 12th week (V3). By the impulse oscillometry system and by spirometry and plethysmography we measured at each visit the fall in resistance from 5 to 20 Hz (R5-R20) and the residual volume/total lung capacity (RV/TLC). COPD Assessment Test (CAT) and the modified Medical Research Council (mMRC) questionnaire were also measured at each visit to assess the impact of the disease on the quality of life of the patients.
Read the detailed description
In recent years, there has been a growing interest in deepening the contribution of small airways (with a diameter <2mm) to the clinical expression of Chronic Obstructive Pulmonary Disease (COPD).
In patients with stable COPD, SAD severity was found to be progressively increased both with the degree of airflow obstruction and with GOLD risk class. Moreover, a correlation between SAD and COPD impact measured with the CAT (COPD Assessment Test) was found, being the severity of SAD a predictor of the impact of the disease (CAT≥10). A close correlation between SAD and both quality of life (measured with the St. George's Respiratory Questionnaire) and perceived dyspnea (measured with the modified Medical Research Council-mMRC scale) was also found in COPD patients.
The exact role of SAD as a specific 'pharmacological target' is not yet fully known. According to the guidelines, the administration of combination such as Beclomethasone dipropionate/Formoterol fumarate (BDP/FF) in extra-fine formulation produced a clinically relevant improvement in quality of life (> 4 units in the St. George's Respiratory Questionnaire) and in dyspnea. However, it is not yet defined whether exists a correlation between symptomatic improvement and SAD and whether an improvement of symptoms can be achieved acting pharmacologically on SAD.
The rationale for this study is based on the hypothesis that an extra-fine formulation of BDP/FF, designed to target the entire bronchial three, included the peripheral zone, can improve the impact of the disease on the quality of life of COPD patients, acting on SAD. The functional indices of SAD used in this study are from the impulse oscillometry system (IOS), the standard spirometry and the body plethysmography.
The primary endpoint of the study was, therefore, an improvement of the impact of the disease on quality of daily life (CAT) and of dyspnea (mMRC) after 12th week treatment with an extra-fine formulation of BDP/FF in a cohort of COPD patients with severe airway obstruction and one moderate exacerbation in a previous year; secondary endpoint was an improvement of the SAD at the 12th week in these patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Beclomethasone Dipropionate/Formoterol Fumarate
- 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.
Beclomethasone Dipropionate/Formoterol FumarateDrug
Also called Foster NEXThaler®
BDP/FF NEXThaler® 100/6 μg b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| 43 COPD | COPD patients with severe airflow obstruction and 1 moderate exacerbation in the previous year being treated with BDP/FF NEXThaler® 100/6 μg b.i.d. for 12 weeks Receives: Drug: Beclomethasone Dipropionate/Formoterol Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (Improvement) of CAT (Italian version)
The CAT (COPD Assessment Test) is a questionnaire suitable for completion by all patients diagnosed with COPD. It comprises 8 simple questions that most patients should be able to understand and complete independently.
The CAT has a scoring range of 0-40, where each question is ranging 0-5. A CAT score>10 indicates a medium/high impact level of COPD.
A difference or change of 2 or more units over 2 to 3 months in a patient suggests a clinically significant difference or change in health status (minimal clinically relevant change, often referred to as the Minimum Clinically Important Difference or MCID).
Measured: Change from Baseline CAT at 12th week
Change (Improvement) of mMRC (Italian version)
The modified Medical Research Council (mMRC) dyspnoea scale is a questionnaire that consists of five statements about perceived breathlessness: grade 1, "I only get breathless with strenuous exercise"; grade 2, "I get short of breath when hurrying on the level or up a slight hill"; grade 3, "I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level"; grade 4, "I stop for breath after walking 100 yards or after a few minutes on the level"; grade 5, " I am too breathless to leave the house". Patients are asked about their perceived breathlessness and are then classified into MRC dyspnoea grades according to how they perceive their disability.
Measured: Change from Baseline mMRC at 12th week
Change (Improvement) of R5-R20 (kPa x s x L-1)
The IOS was performed with the Jaeger MasterScreen-IOS device following the standard recommendations. Respiratory resistances at 5 Hz and 20 Hz (R5 and R20, kPa x s x L-1) were used as a total and proximal airway resistance index, respectively, and the resistance drop from 5 to 20 Hz (R5 - R20, kPa x s x L-1) was considered as an indirect index of resistance of the peripheral airways. The oscillometer was calibrated daily.
Measured: Change from Baseline R5-R20 at 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start31 May 2017
- Primary completion8 Feb 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfredo Antonio Chetta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma
- Responsible party
- Sponsor-investigator, Alfredo Antonio Chetta, University of Parma
- Investigators
- Alfredo A Chetta, MD, Principal investigator, Hospital-University of Parma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421742
- Sponsor's protocol ID
- 9769 del 15.03.2017
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected in this study are available to other researches
Publications
Burgel PR. The role of small airways in obstructive airway diseases. Eur Respir Rev. 2011 Mar;20(119):23-33. doi: 10.1183/09059180.00010410.
PubMed 21357889Hogg JC, Chu F, Utokaparch S, Woods R, Elliott WM, Buzatu L, Cherniack RM, Rogers RM, Sciurba FC, Coxson HO, Pare PD. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med. 2004 Jun 24;350(26):2645-53. doi: 10.1056/NEJMoa032158.
PubMed 15215480Crisafulli E, Pisi R, Aiello M, Vigna M, Tzani P, Torres A, Bertorelli G, Chetta A. Prevalence of Small-Airway Dysfunction among COPD Patients with Different GOLD Stages and Its Role in the Impact of Disease. Respiration. 2017;93(1):32-41. doi: 10.1159/000452479. Epub 2016 Nov 17.
PubMed 27852080Wedzicha JA, Singh D, Vestbo J, Paggiaro PL, Jones PW, Bonnet-Gonod F, Cohuet G, Corradi M, Vezzoli S, Petruzzelli S, Agusti A; FORWARD Investigators. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153-62. doi: 10.1016/j.rmed.2014.05.013. Epub 2014 Jun 6.
PubMed 24953015Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
PubMed 7722560George J, Kong DC, Thoman R, Stewart K. Factors associated with medication nonadherence in patients with COPD. Chest. 2005 Nov;128(5):3198-204. doi: 10.1378/chest.128.5.3198.
PubMed 16304262Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. No abstract available.
PubMed 8499054Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
PubMed 14680096Oppenheimer BW, Goldring RM, Herberg ME, Hofer IS, Reyfman PA, Liautaud S, Rom WN, Reibman J, Berger KI. Distal airway function in symptomatic subjects with normal spirometry following World Trade Center dust exposure. Chest. 2007 Oct;132(4):1275-82. doi: 10.1378/chest.07-0913. Epub 2007 Sep 21.
PubMed 17890470Kon SS, Canavan JL, Jones SE, Nolan CM, Clark AL, Dickson MJ, Haselden BM, Polkey MI, Man WD. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014 Mar;2(3):195-203. doi: 10.1016/S2213-2600(14)70001-3. Epub 2014 Feb 4.
PubMed 24621681Han MK, Quibrera PM, Carretta EE, Barr RG, Bleecker ER, Bowler RP, Cooper CB, Comellas A, Couper DJ, Curtis JL, Criner G, Dransfield MT, Hansel NN, Hoffman EA, Kanner RE, Krishnan JA, Martinez CH, Pirozzi CB, O'Neal WK, Rennard S, Tashkin DP, Wedzicha JA, Woodruff P, Paine R 3rd, Martinez FJ; SPIROMICS investigators. Frequency of exacerbations in patients with chronic obstructive pulmonary disease: an analysis of the SPIROMICS cohort. Lancet Respir Med. 2017 Aug;5(8):619-626. doi: 10.1016/S2213-2600(17)30207-2. Epub 2017 Jun 28.
PubMed 28668356Hogg JC, Chu FS, Tan WC, Sin DD, Patel SA, Pare PD, Martinez FJ, Rogers RM, Make BJ, Criner GJ, Cherniack RM, Sharafkhaneh A, Luketich JD, Coxson HO, Elliott WM, Sciurba FC. Survival after lung volume reduction in chronic obstructive pulmonary disease: insights from small airway pathology. Am J Respir Crit Care Med. 2007 Sep 1;176(5):454-9. doi: 10.1164/rccm.200612-1772OC. Epub 2007 Jun 7.
PubMed 17556723Basile M, Baiamonte P, Mazzuca E, Principe S, Pennavaria F, Benfante A, Scichilone N. Sleep Disturbances in COPD are Associated with Heterogeneity of Airway Obstruction. COPD. 2018 Jun-Aug;15(4):350-354. doi: 10.1080/15412555.2018.1504015. Epub 2018 Sep 6.
PubMed 30188194De Backer W, Devolder A, Poli G, Acerbi D, Monno R, Herpich C, Sommerer K, Meyer T, Mariotti F. Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients. J Aerosol Med Pulm Drug Deliv. 2010 Jun;23(3):137-48. doi: 10.1089/jamp.2009.0772.
PubMed 20109122de Boer AH, Gjaltema D, Hagedoorn P, Frijlink HW. Can 'extrafine' dry powder aerosols improve lung deposition? Eur J Pharm Biopharm. 2015 Oct;96:143-51. doi: 10.1016/j.ejpb.2015.07.016. Epub 2015 Jul 26.
PubMed 26220014
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and Dyspnea is Associated to the Improvement in Small Airway Dysfunction in COPD Patients. A Pilot Study (IOSCOPD20161102)
- ClinicalTrials.gov ID
- NCT04421742
- Acronym / sponsor ID
- 9769 del 15.03.2017
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Alfredo Antonio ChettaUniversity, hospital or other
- Collaborators
- University of Parma
- Study start
- 31 May 2017 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 9 Jun 2020 (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.
In patients with chronic obstructive pulmonary disease (COPD), small-airway dysfunction (SAD) is considered a key element and a functional consequence of the pathology. However, the exact role of SAD as a specific 'pharmacological target' is not yet fully known.
Objectives In an open-label prospective study, we aimed to ascertain whether an extra-fine formulation of Beclomethasone dipropionate/Formoterol fumarate (BDP/FF) NEXThaler® 100/6 μg b.i.d. can improve the impact of the disease on the quality of daily life of COPD patients, acting on SAD.
Methods We studied COPD patients with severe airflow obstruction and 1 moderate exacerbation in the previous year, being treated with BDP/FF NEXThaler® for 12 weeks. They underwent three visits, at the start of the treatment (V1), at 6th week (V2) and at 12th week (V3). By the impulse oscillometry system and by spirometry and plethysmography we measured at each visit the fall in resistance from 5 to 20 Hz (R5-R20) and the residual volume/total lung capacity (RV/TLC). COPD Assessment Test (CAT) and the modified Medical Research Council (mMRC) questionnaire were also measured at each visit to assess the impact of the disease on the quality of life of the patients.
Detailed description
In recent years, there has been a growing interest in deepening the contribution of small airways (with a diameter <2mm) to the clinical expression of Chronic Obstructive Pulmonary Disease (COPD).
In patients with stable COPD, SAD severity was found to be progressively increased both with the degree of airflow obstruction and with GOLD risk class. Moreover, a correlation between SAD and COPD impact measured with the CAT (COPD Assessment Test) was found, being the severity of SAD a predictor of the impact of the disease (CAT≥10). A close correlation between SAD and both quality of life (measured with the St. George's Respiratory Questionnaire) and perceived dyspnea (measured with the modified Medical Research Council-mMRC scale) was also found in COPD patients.
The exact role of SAD as a specific 'pharmacological target' is not yet fully known. According to the guidelines, the administration of combination such as Beclomethasone dipropionate/Formoterol fumarate (BDP/FF) in extra-fine formulation produced a clinically relevant improvement in quality of life (> 4 units in the St. George's Respiratory Questionnaire) and in dyspnea. However, it is not yet defined whether exists a correlation between symptomatic improvement and SAD and whether an improvement of symptoms can be achieved acting pharmacologically on SAD.
The rationale for this study is based on the hypothesis that an extra-fine formulation of BDP/FF, designed to target the entire bronchial three, included the peripheral zone, can improve the impact of the disease on the quality of life of COPD patients, acting on SAD. The functional indices of SAD used in this study are from the impulse oscillometry system (IOS), the standard spirometry and the body plethysmography.
The primary endpoint of the study was, therefore, an improvement of the impact of the disease on quality of daily life (CAT) and of dyspnea (mMRC) after 12th week treatment with an extra-fine formulation of BDP/FF in a cohort of COPD patients with severe airway obstruction and one moderate exacerbation in a previous year; secondary endpoint was an improvement of the SAD at the 12th week in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 43 COPD | – | Drug: Beclomethasone Dipropionate/Formoterol FumarateCOPD patients with severe airflow obstruction and 1 moderate exacerbation in the previous year being treated with BDP/FF NEXThaler® 100/6 μg b.i.d. for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients of the outpatient clinic of the Respiratory Disease Unit of the University Hospital in Parma (Italy)
Key inclusion criteria (6 listed)
- a documented diagnosis of COPD defined according to the guidelines of the American Thoracic Society (ATS) / European Respiratory Society (ERS);
- smokers or former smokers with a smoking history of at least 10 pack / years;
- subjects with a post-bronchodilator forced expiratory volume at the 1st second (FEV1)/ forced vital capacity (FVC) ratio of < 0.7 and a FEV1 <50% pred;
- subjects with a high impact of the COPD on their health status (CAT≥10);
- clinical history of at least 1 moderate exacerbation / year;
Key exclusion criteria (4 listed)
- an exacerbation in the four weeks prior to enrollment;
- other coexisting lung diseases (bronchial asthma, restrictive diseases or bronchiectasis) and severe co-morbidities associated with COPD, such as uncontrolled cardiovascular disease, pneumonia or cancer;
- pregnant patients;
- subjects unable to meet the criteria of acceptability and repeatability of pulmonary function tests, according to the ATS / ERS document
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 |
|---|---|---|
| Beclomethasone Dipropionate/Formoterol FumarateAlso: Foster NEXThaler®BDP/FF NEXThaler® 100/6 μg b.i.d. | Drug | 43 COPD |
Primary outcome
Change (Improvement) of CAT (Italian version)
Time frame: Change from Baseline CAT at 12th week
The CAT (COPD Assessment Test) is a questionnaire suitable for completion by all patients diagnosed with COPD. It comprises 8 simple questions that most patients should be able to understand and complete independently. The CAT has a scoring range of 0-40, where each question is ranging 0-5. A CAT score>10 indicates a medium/high impact level of COPD. A difference or change of 2 or more units over 2 to 3 months in a patient suggests a clinically significant difference or change in health status (minimal clinically relevant change, often referred to as the Minimum Clinically Important Difference or MCID).
Change (Improvement) of mMRC (Italian version)
Time frame: Change from Baseline mMRC at 12th week
The modified Medical Research Council (mMRC) dyspnoea scale is a questionnaire that consists of five statements about perceived breathlessness: grade 1, "I only get breathless with strenuous exercise"; grade 2, "I get short of breath when hurrying on the level or up a slight hill"; grade 3, "I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level"; grade 4, "I stop for breath after walking 100 yards or after a few minutes on the level"; grade 5, " I am too breathless to leave the house". Patients are asked about their perceived breathlessness and are then classified into MRC dyspnoea grades according to how they perceive their disability.
Change (Improvement) of R5-R20 (kPa x s x L-1)
Time frame: Change from Baseline R5-R20 at 12th week
The IOS was performed with the Jaeger MasterScreen-IOS device following the standard recommendations. Respiratory resistances at 5 Hz and 20 Hz (R5 and R20, kPa x s x L-1) were used as a total and proximal airway resistance index, respectively, and the resistance drop from 5 to 20 Hz (R5 - R20, kPa x s x L-1) was considered as an indirect index of resistance of the peripheral airways. The oscillometer was calibrated daily.
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 9 Jun 2020.
- Results publication: PubMed 21357889Burgel PR. The role of small airways in obstructive airway diseases. Eur Respir Rev. 2011 Mar;20(119):23-33. doi: 10.1183/09059180.00010410.
- Results publication: PubMed 15215480Hogg JC, Chu F, Utokaparch S, Woods R, Elliott WM, Buzatu L, Cherniack RM, Rogers RM, Sciurba FC, Coxson HO, Pare PD. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med. 2004 Jun 24;350(26):2645-53. doi: 10.1056/NEJMoa032158.
- Results publication: PubMed 27852080Crisafulli E, Pisi R, Aiello M, Vigna M, Tzani P, Torres A, Bertorelli G, Chetta A. Prevalence of Small-Airway Dysfunction among COPD Patients with Different GOLD Stages and Its Role in the Impact of Disease. Respiration. 2017;93(1):32-41. doi: 10.1159/000452479. Epub 2016 Nov 17.
- Results publication: PubMed 24953015Wedzicha JA, Singh D, Vestbo J, Paggiaro PL, Jones PW, Bonnet-Gonod F, Cohuet G, Corradi M, Vezzoli S, Petruzzelli S, Agusti A; FORWARD Investigators. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153-62. doi: 10.1016/j.rmed.2014.05.013. Epub 2014 Jun 6.
- Results publication: PubMed 7722560Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
- Results publication: PubMed 16304262George J, Kong DC, Thoman R, Stewart K. Factors associated with medication nonadherence in patients with COPD. Chest. 2005 Nov;128(5):3198-204. doi: 10.1378/chest.128.5.3198.
- Results publication: PubMed 8499054Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. No abstract available.
- Results publication: PubMed 14680096Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
- Results publication: PubMed 17890470Oppenheimer BW, Goldring RM, Herberg ME, Hofer IS, Reyfman PA, Liautaud S, Rom WN, Reibman J, Berger KI. Distal airway function in symptomatic subjects with normal spirometry following World Trade Center dust exposure. Chest. 2007 Oct;132(4):1275-82. doi: 10.1378/chest.07-0913. Epub 2007 Sep 21.
- Results publication: PubMed 24621681Kon SS, Canavan JL, Jones SE, Nolan CM, Clark AL, Dickson MJ, Haselden BM, Polkey MI, Man WD. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014 Mar;2(3):195-203. doi: 10.1016/S2213-2600(14)70001-3. Epub 2014 Feb 4.
- Results publication: PubMed 28668356Han MK, Quibrera PM, Carretta EE, Barr RG, Bleecker ER, Bowler RP, Cooper CB, Comellas A, Couper DJ, Curtis JL, Criner G, Dransfield MT, Hansel NN, Hoffman EA, Kanner RE, Krishnan JA, Martinez CH, Pirozzi CB, O'Neal WK, Rennard S, Tashkin DP, Wedzicha JA, Woodruff P, Paine R 3rd, Martinez FJ; SPIROMICS investigators. Frequency of exacerbations in patients with chronic obstructive pulmonary disease: an analysis of the SPIROMICS cohort. Lancet Respir Med. 2017 Aug;5(8):619-626. doi: 10.1016/S2213-2600(17)30207-2. Epub 2017 Jun 28.
- Results publication: PubMed 17556723Hogg JC, Chu FS, Tan WC, Sin DD, Patel SA, Pare PD, Martinez FJ, Rogers RM, Make BJ, Criner GJ, Cherniack RM, Sharafkhaneh A, Luketich JD, Coxson HO, Elliott WM, Sciurba FC. Survival after lung volume reduction in chronic obstructive pulmonary disease: insights from small airway pathology. Am J Respir Crit Care Med. 2007 Sep 1;176(5):454-9. doi: 10.1164/rccm.200612-1772OC. Epub 2007 Jun 7.
- Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018Link provided by the sponsor.
- CAT Development Steering Group: COPD Assessment Test - Healthcare Professional User Guide. Issue 4: November 2018.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data collected in this study are available to other researches
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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.
Alfredo A Chetta, MD principal investigator
Hospital-University of Parma, Italy
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 Alfredo Antonio Chetta at 1 site 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 6 inclusion and 4 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 9 Jun 2020. 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 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?
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?
Change (Improvement) of CAT (Italian version) (time frame: Change from Baseline CAT at 12th week). The study lists 3 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 NCT04421742, which also lists 18 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 9 Jun 2020.