Chronic Obstructive Pulmonary Disease (COPD)Phase 3TRIBUTENCT02579850
2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients
A Phase 3 study testing Central spirometry, COPD assessment test and Local laboratory Assessments in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial summary
The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Central spirometry, COPD assessment test and Local laboratory Assessments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,532 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2015to 10 Jul 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Male and female ≥ 40 years
- Severe or very severe COPD diagnosed for at least 12 months
- Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
- Post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7
- Documented history of at least one exacerbation in the 12 months
- Patient under double therapy for at least 2 months prior to screening. Double therapy will be defined by treatment with any of the following:
Show all 9Show fewer
- Orally inhaled corticosteroid (ICS) and (long-acting beta2-agonist) LABA ICS and long-acting muscarinic antagonist (LAMA) Orally LABA and LAMA Monotherapy with LAMA for at least 2 months prior to screening
- Symptomatic patient at screening with a CAT score ≥ 10.
- Cooperative attitude and ability to use correctly the inhalers, the spacer AeroChamber Plus (only to patients who are using a spacer), the electronic devices with COPD questionnaire.
Who cannot join
- Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS are willing to use one or more of the reliable methods of contraception
- Patient with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy
- Patient requiring use of the following medications:
- Course of systemic steroids > 3 days for COPD exacerbation in the 4 weeks prior to screening Course of antibiotics for COPD exacerbation > 7 days in the 4 weeks prior to screening Phosphodiesterase-4 inhibitor in the 4 weeks prior to screening Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening
- COPD exacerbation requiring prescription of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period
- Patient treated with non-cardioselective β-blockers in the month preceding the screening or during the run-in period.
Show all 21Show fewer
- Patient treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as needed
- Patient requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
- Known respiratory disorders other than COPD which may impact the efficacy of the study drug
- Patient who have clinically significant cardiovascular condition
- Patient with atrial fibrillation (AF): Paroxysmal atrial fibrillation, Persistent, Long standing or Permanent
- Abnormal and clinically significant 12-lead ECG that results in active medical problem which may impact the safety of the patient
- Patient whose ECG shows QTcF >450 ms for males or QTcF >470 ms for females at screening visit are not eligible (not applicable for patient with pacemaker)
- Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction would prevent use of anticholinergic agents
- History of hypersensitivity to M3 Antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug
- Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug
- Patients with hypokalaemia (serum potassium <3.5 mEq/L or 3.5 mmol/L) or uncontrolled hyperkalaemia
- Unstable concurrent disease which may impact the results of the study
- Patients with any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next six months (after V1) or with malignancy for which they are currently undergoing radiation therapy or chemotherapy
- History of alcohol abuse or substance/drug abuse within 12 months prior to screening visit
- Participation in another clinical trial if investigational drug was received less than 8 weeks prior to screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 52-week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients
The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.
Read the detailed description
Outpatients attending the hospital clinics/study centres will be recruited. Patients with severe and very severe COPD airflow obstruction according to GOLD 2014 criteria. A total of approximately 2192 patients will need to be screened in order to obtain 1534 (767 per arm) randomized and evaluable patients. Approximately 200 sites will be involved worldwide.
Each patient will perform a total of 8 clinic visits (V0 to V7) during the study.
The Primary objective is to demonstrate the superiority of CHF 5993 pMDI over Ultibro® in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.
The Secondary objectives are:
- To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures;
- To assess the safety and the tolerability of the study treatments.
A 2-week open-label run-in period under Ultibro® followed by a 52-week randomised treatment period.
The trial design will be optimised to measure exacerbation rates by using the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), developed means of collecting patient-reported outcome (PRO) data, which helps to capture the frequency of exacerbations.
- Being tested
- CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo, Central spirometry, COPD assessment test, Local laboratory Assessments
- Keywords
- COPD, COPD Exacerbation, EXACT-PRO
- 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.
CHF 5993 + Ultibro matched placeboDrug
Also called CHF 5993
Active medication treatment CHF 5993 and Ultibro matched placebo administered twice a day
Ultibro + CHF 5993 matched placeboDrug
Also called Ultibro Breezhaler
Active medication treatment Ultibro and CHF 5993 matched placebo administered twice a day
Central spirometryProcedure or surgery
Central spirometry to assess forced expiratory volume at one second and forced vital capacity
COPD assessment testOther
COPD assessment test (CAT) at visit 1
Local laboratory AssessmentsProcedure or surgery
ECG + Standard Haematology and Biochemistry
Saint George's Respiratory QuestionnaireOther
Saint George's Respiratory Questionnaire
EXACT-pro questionnaireOther
daily from randomization (Visit 2) to end of study (Visit 7)
| Study group | Role | What they receive |
|---|---|---|
| CHF 5993 + Ultibro matched placebo | Experimental | Fixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire Receives: Drug: CHF 5993 + Ultibro matched placebo; Procedure: Central spirometry; Other: COPD assessment test; Procedure: Local laboratory Assessments; Other: Saint George's Respiratory Questionnaire; Other: EXACT-pro questionnaire |
| Ultibro + CHF 5993 matched placebo | Active comparator | Fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire Receives: Drug: Ultibro + CHF 5993 matched placebo; Procedure: Central spirometry; Other: COPD assessment test; Procedure: Local laboratory Assessments; Other: Saint George's Respiratory Questionnaire; Other: EXACT-pro questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate and severe COPD exacerbation rate over 52 weeks of treatment
Exacerbations will be evaluated at each study visit and collected using EXACT-PRO filled-in by patient every day throughout the study
Measured: 1 year
Secondary outcomes (4)
Time to first moderate to severe COPD exacerbation
Measured: 1 year
Rate of severe COPD exacerbation over 52 weeks of treatment
Measured: 1 year
Rate of moderate COPD exacerbation over 52 weeks of treatment
Measured: 1 year
Change from Baseline at each visit and over the entire treatment period in pre-dose morning FEV1
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 posted20 Oct 2015 (estimated)
- Study start29 May 2015
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Scuri, MD, Study chair, Chiesi Farmaceutici S.p.A.Nicolas Roche, Pr, Principal investigator, Hopitaux Universitaires Paris Centre - Groupe Hospitalier Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579850
- Sponsor's protocol ID
- CCD-05993AA1-08
- Other IDs
- 2014-001704-22, 2014
- Acronym
- TRIBUTE
- Status last verified
- Oct 2021
- First submitted
- 12 May 2015
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
Publications
Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, Celli B. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. Int J Chron Obstruct Pulmon Dis. 2018 Dec 12;13:3971-3981. doi: 10.2147/COPD.S185975. eCollection 2018.
PubMed 30587953Singh D, Fabbri LM, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. Int J Chron Obstruct Pulmon Dis. 2019 Feb 28;14:531-546. doi: 10.2147/COPD.S196383. eCollection 2019.
PubMed 30880943Singh D, Fabbri LM, Corradi M, Georges G, Guasconi A, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation. Eur Respir J. 2019 May 18;53(5):1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May.
PubMed 30792343Papi A, Petruzzelli S, Vezzoli S, Georges G, Fabbri LM. Triple therapy for all patients with severe symptomatic COPD at risk of exacerbations. Eur Respir J. 2019 Apr 18;53(4):1900147. doi: 10.1183/13993003.00147-2019. Print 2019 Apr. No abstract available.
PubMed 31000665Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, Guasconi A, Montagna I, Vezzoli S, Petruzzelli S, Scuri M, Roche N, Singh D. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018 Mar 17;391(10125):1076-1084. doi: 10.1016/S0140-6736(18)30206-X. Epub 2018 Feb 9.
PubMed 29429593
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 52-week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients
- ClinicalTrials.gov ID
- NCT02579850
- Acronym / sponsor ID
- TRIBUTE / CCD-05993AA1-08
- Keywords
- COPD, COPD Exacerbation, EXACT-PRO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,532 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 29 May 2015 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 20 Oct 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.
The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.
Detailed description
Outpatients attending the hospital clinics/study centres will be recruited. Patients with severe and very severe COPD airflow obstruction according to GOLD 2014 criteria. A total of approximately 2192 patients will need to be screened in order to obtain 1534 (767 per arm) randomized and evaluable patients. Approximately 200 sites will be involved worldwide.
Each patient will perform a total of 8 clinic visits (V0 to V7) during the study.
The Primary objective is to demonstrate the superiority of CHF 5993 pMDI over Ultibro® in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.
The Secondary objectives are:
- To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures;
- To assess the safety and the tolerability of the study treatments.
A 2-week open-label run-in period under Ultibro® followed by a 52-week randomised treatment period.
The trial design will be optimised to measure exacerbation rates by using the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), developed means of collecting patient-reported outcome (PRO) data, which helps to capture the frequency of exacerbations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF 5993 + Ultibro matched placebo | Experimental | Drug: CHF 5993 + Ultibro matched placebo, Procedure: Central spirometry, Other: COPD assessment test, Procedure: Local laboratory Assessments, Other: Saint George's Respiratory Questionnaire, Other: EXACT-pro questionnaireFixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment. Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study. 7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire |
| Ultibro + CHF 5993 matched placebo | Active comparator | Drug: Ultibro + CHF 5993 matched placebo, Procedure: Central spirometry, Other: COPD assessment test, Procedure: Local laboratory Assessments, Other: Saint George's Respiratory Questionnaire, Other: EXACT-pro questionnaireFixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment. Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study. 7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female ≥ 40 years
- Severe or very severe COPD diagnosed for at least 12 months
- Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
- Post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7
- Documented history of at least one exacerbation in the 12 months
Key exclusion criteria (21 listed)
- Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS are willing to use one or more of the reliable methods of contraception
- Patient with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy
- Patient requiring use of the following medications:
- Course of systemic steroids > 3 days for COPD exacerbation in the 4 weeks prior to screening Course of antibiotics for COPD exacerbation > 7 days in the 4 weeks prior to screening Phosphodiesterase-4 inhibitor in the 4 weeks prior to screening Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening
- COPD exacerbation requiring prescription of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period
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 |
|---|---|---|
| CHF 5993 + Ultibro matched placeboAlso: CHF 5993Active medication treatment CHF 5993 and Ultibro matched placebo administered twice a day | Drug | CHF 5993 + Ultibro matched placebo |
| Ultibro + CHF 5993 matched placeboAlso: Ultibro BreezhalerActive medication treatment Ultibro and CHF 5993 matched placebo administered twice a day | Drug | Ultibro + CHF 5993 matched placebo |
| Central spirometryCentral spirometry to assess forced expiratory volume at one second and forced vital capacity | Procedure or surgery | CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo |
| COPD assessment testCOPD assessment test (CAT) at visit 1 | Other | CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo |
| Local laboratory AssessmentsECG + Standard Haematology and Biochemistry | Procedure or surgery | CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo |
| Saint George's Respiratory QuestionnaireSaint George's Respiratory Questionnaire | Other | CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo |
| EXACT-pro questionnairedaily from randomization (Visit 2) to end of study (Visit 7) | Other | CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo |
Primary outcome
Moderate and severe COPD exacerbation rate over 52 weeks of treatment
Time frame: 1 year
Exacerbations will be evaluated at each study visit and collected using EXACT-PRO filled-in by patient every day throughout the study
4 secondary outcomes
Time to first moderate to severe COPD exacerbation
Time frame: 1 year
Rate of severe COPD exacerbation over 52 weeks of treatment
Time frame: 1 year
Rate of moderate COPD exacerbation over 52 weeks of treatment
Time frame: 1 year
Change from Baseline at each visit and over the entire treatment period in pre-dose morning FEV1
Time frame: 1 year
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 Oct 2021.
- Background: PubMed 30587953Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, Celli B. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. Int J Chron Obstruct Pulmon Dis. 2018 Dec 12;13:3971-3981. doi: 10.2147/COPD.S185975. eCollection 2018.
- Background: PubMed 30880943Singh D, Fabbri LM, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. Int J Chron Obstruct Pulmon Dis. 2019 Feb 28;14:531-546. doi: 10.2147/COPD.S196383. eCollection 2019.
- Background: PubMed 30792343Singh D, Fabbri LM, Corradi M, Georges G, Guasconi A, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation. Eur Respir J. 2019 May 18;53(5):1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May.
- Background: PubMed 31000665Papi A, Petruzzelli S, Vezzoli S, Georges G, Fabbri LM. Triple therapy for all patients with severe symptomatic COPD at risk of exacerbations. Eur Respir J. 2019 Apr 18;53(4):1900147. doi: 10.1183/13993003.00147-2019. Print 2019 Apr. No abstract available.
- Results publication: PubMed 29429593Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, Guasconi A, Montagna I, Vezzoli S, Petruzzelli S, Scuri M, Roche N, Singh D. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018 Mar 17;391(10125):1076-1084. doi: 10.1016/S0140-6736(18)30206-X. Epub 2018 Feb 9.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
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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.
Mario Scuri, MD study chair
Chiesi Farmaceutici S.p.A.
Nicolas Roche, Pr principal investigator
Hopitaux Universitaires Paris Centre - Groupe Hospitalier Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Central spirometry, COPD assessment test and Local laboratory Assessments in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. 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 9 inclusion and 21 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 Oct 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Moderate and severe COPD exacerbation rate over 52 weeks of treatment (time frame: 1 year). 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 NCT02579850, which also lists 5 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 Oct 2021.