COPDNCT03963167
Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)
An observational study of COPD, run by Chiesi Italia at 1 site in Italy.
Trial summary
The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- BDP/FF/G fixed combination
- How many people
- 661 participants
- Where
- 1 siteItaly
- Study dates
- 21 Aug 2019to 4 Mar 2022
- 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: COPD patients with symptoms and history of exacerbations despite of maintenance therapy
Who may be able to join
- Written informed consent to participate in the study;
- Adult patients of either sex aged ≥ 40 years;
- Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4);
- COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;
- History of >1 moderate or severe COPD exacerbation during the previous year.
- Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC).
Who cannot join
- According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation;
- Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact on the Health Status and Adherence in a Real-life Setting of Italian Patients With Chronic Obstructive Pulmonary Disease in Treatment With Trimbow® pMDI b.i.d.: a 12-month Prospective Observational Study
The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence
- Conditions
- COPD
- Being tested
- BDP/FF/G fixed combination
- Keywords
- COPD, Adherence, HRQoL determinants
- 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.
BDP/FF/G fixed combinationDrug
Also called Trimbow
Fixed combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G).
| Study group | Role | What they receive |
|---|---|---|
| Patient in treatment with BDP/FF/G fixed combination | Not described Receives: Drug: BDP/FF/G fixed combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COPD Assessment Test (CAT) score
CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life.
Measured: 12 months
Secondary outcomes (13)
Change in COPD Assessment Test (CAT) score
CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life.
Measured: 6 months
Change in 12-item Test of Adherence to Inhalers (TAI-12) score
TAI comprises a patient domain (including 10 items) and a healthcare professional domain (including 2 items). Each item ranges from 1 (lowest adherence) to 5 (highest adherence) points. The patient domain score ranges from 10 to 50. Adherence is rated as good (score =50), intermediate (score = 46-49), or poor (score ≤45). The questions for healthcare professionals are scored with 1 or 2 points (poor or good knowledge of the regimen and/or inhalation technique).
Measured: 6 and 12 months
Change in COPD and Asthma Sleep Impact Scale (CASIS) score
It is a self-administered 7-item scale scored on a five-point scale ranging from 0 if the item never applies, to 4 if the item applies very often. A total raw score is produced from the sum of the seven individual scores which is then linearly transformed to a 0-100 total scale score. Higher scores representing greater sleep deterioration in the previous week.
Measured: 6 and 12 months
Change in EuroQoL score
Il consists of 2 pages, a descriptive system and a visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.The VAS records the respondent's self-rated health on a 10 cm vertical VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Measured: 6 and 12 months
Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)
it contains 8 questions, each scored on a 0-5 Likert scale, which range from 0 (fully disagree) to 5 (fully agree), for a total maximum score of 40. Higher scores indicate a higher ease of use and satisfaction with the inhaler
Measured: 6 and 12 months
Forced Expiratory Volume in the first second (FEV1, L)
Measured: Baseline, 6 and 12 months
Forced Vital Capacity (FVC, L)
Measured: Baseline, 6 and 12 months
Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75)
Taken from the test with the highest values of FEV1 and FVC
Measured: Baseline, 6 and 12 months
Ratio FEV1/FVC
Derived from these highest values of each parameter
Measured: Baseline, 6 and 12 months
Use of rescue medication
Use of rescue medication
Measured: Baseline, 6 and 12 months
Exacerbations
Moderate to severe exacerbations
Measured: Baseline, 6 and 12 months
Adverse events
Number of adverse events
Measured: Baseline, 6 and 12 months
Economic resources consumption
Number of hospitalizations, ER access, unscheduled visits
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start21 Aug 2019
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Italia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca Richeldi, MD, Principal investigator, Policlinico Gemelli, Roma (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963167
- Sponsor's protocol ID
- DFIDM-1802
- Status last verified
- Feb 2026
- First submitted
- 14 May 2019
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richeldi L, Piraino A, Macagno F, Micarelli G, Ingrassia E. The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol. Int J Chron Obstruct Pulmon Dis. 2021 Jan 27;16:159-166. doi: 10.2147/COPD.S286559. eCollection 2021.
PubMed 33536751Richeldi L, Schino P, Bargagli E, Ricci A, Rocca A, Marchesani F, Pennisi A, Camiciottoli G, D'Amato M, Macagno F, Scaffidi Argentina U, Ingrassia E, Piraino A. TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life. Int J Chron Obstruct Pulmon Dis. 2024 Feb 23;19:475-487. doi: 10.2147/COPD.S445858. eCollection 2024.
PubMed 38435125
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on the Health Status and Adherence in a Real-life Setting of Italian Patients With Chronic Obstructive Pulmonary Disease in Treatment With Trimbow® pMDI b.i.d.: a 12-month Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03963167
- Acronym / sponsor ID
- DFIDM-1802
- Conditions
- COPD
- Keywords
- COPD, Adherence, HRQoL determinants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Chiesi ItaliaIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 24 May 2019 (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 mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient in treatment with BDP/FF/G fixed combination | – | Drug: BDP/FF/G fixed combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with symptoms and history of exacerbations despite of maintenance therapy
Key inclusion criteria (6 listed)
- Written informed consent to participate in the study;
- Adult patients of either sex aged ≥ 40 years;
- Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4);
- COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;
- History of >1 moderate or severe COPD exacerbation during the previous year.
Key exclusion criteria (2 listed)
- According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation;
- Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.
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 |
|---|---|---|
| BDP/FF/G fixed combinationAlso: TrimbowFixed combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G). | Drug | Patient in treatment with BDP/FF/G fixed combination |
Primary outcome
Change in COPD Assessment Test (CAT) score
Time frame: 12 months
CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life.
13 secondary outcomes
Change in COPD Assessment Test (CAT) score
Time frame: 6 months
Change in 12-item Test of Adherence to Inhalers (TAI-12) score
Time frame: 6 and 12 months
Change in COPD and Asthma Sleep Impact Scale (CASIS) score
Time frame: 6 and 12 months
Change in EuroQoL score
Time frame: 6 and 12 months
Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)
Time frame: 6 and 12 months
Forced Expiratory Volume in the first second (FEV1, L)
Time frame: Baseline, 6 and 12 months
Forced Vital Capacity (FVC, L)
Time frame: Baseline, 6 and 12 months
Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75)
Time frame: Baseline, 6 and 12 months
Ratio FEV1/FVC
Time frame: Baseline, 6 and 12 months
Use of rescue medication
Time frame: Baseline, 6 and 12 months
Exacerbations
Time frame: Baseline, 6 and 12 months
Adverse events
Time frame: Baseline, 6 and 12 months
Economic resources consumption
Time frame: Baseline, 6 and 12 months
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 20 Feb 2026.
- Background: PubMed 33536751Richeldi L, Piraino A, Macagno F, Micarelli G, Ingrassia E. The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol. Int J Chron Obstruct Pulmon Dis. 2021 Jan 27;16:159-166. doi: 10.2147/COPD.S286559. eCollection 2021.
- Results publication: PubMed 38435125Richeldi L, Schino P, Bargagli E, Ricci A, Rocca A, Marchesani F, Pennisi A, Camiciottoli G, D'Amato M, Macagno F, Scaffidi Argentina U, Ingrassia E, Piraino A. TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life. Int J Chron Obstruct Pulmon Dis. 2024 Feb 23;19:475-487. doi: 10.2147/COPD.S445858. eCollection 2024.
- 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.
Luca Richeldi, MD principal investigator
Policlinico Gemelli, Roma (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 COPD, run by Chiesi Italia 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 2 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 20 Feb 2026. 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 in COPD Assessment Test (CAT) score (time frame: 12 months). 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 NCT03963167, which also lists 2 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 20 Feb 2026.