COPD (Chronic Obstructive Pulmonary Disease)OCTRISNCT06931899
Oscillometry in the COPD Exacerbator Phenotype With Triple Inhaled Therapy Study
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The objective of this observational study is to determine the effectiveness of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) and frequent worsening of their respiratory symptoms by using a device called an oscillometer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2025to Aug 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with exacerbating COPD from the pulmonology clinics of 6 hospitals in Catalonia, Spain.
Who may be able to join
- Age over 18 years.
- Diagnosis of COPD.
- Severe-moderate COPD measured by FEV1 and stable.
- Patient receiving dual bronchodilation therapy (LABA/LAMA) for at least the last 4 months prior to study inclusion and meeting clinical criteria to begin triple inhaled therapy.
- COPD exacerbations (COPD exacerbations).
- Blood eosinophils >100 cells/mL in prior laboratory tests.
- Patient agrees to participate in the study and signs the informed consent form.
Who cannot join
- COPD in the last 4 weeks, with use of antibiotics or systemic corticosteroids.
- Chronic lung disease other than COPD.
- Severe heart failure, with frequent decompensation (in cases of mild decompensation or onset without severe heart disease, do not include the patient within 3 months of decompensation).
- Active neoplastic processes.
- Severe renal failure.
- 5. ALT greater than 2.5 times the upper limit of normal. 6. Poorly controlled insulin-dependent diabetes or involvement of 1 or more organs.
- 7. Positive COVID-19 test (do not include until 3 months after diagnosis by ART or COVID-19 PCR).
- 8. Previous treatment with ICS in the last 4 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Usefulness of Oscillometry in Assessing the Effectiveness of Inhaled Corticosteroides in Patients With COPD Exacerbator Phenotype
The objective of this observational study is to determine the effectiveness of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) and frequent worsening of their respiratory symptoms by using a device called an oscillometer. This instrument is capable of measuring bronchial obstruction and air trapping in the lungs through vibrations during normal breathing. The main question it seeks to answer is:
Could oscillometry be useful in assessing the effectiveness of inhaled corticosteroids in patients with COPD exacerbations, in terms of bronchial obstruction and air trapping in the lungs? Patients who choose to participate will undergo oscillometry testing and complete standard COPD questionnaires during three follow-up visits spread over three months.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the most prevalent chronic respiratory disease worldwide, estimated at around 12% in Spain and 17.3% in Catalonia, despite significant underdiagnosis of up to approximately 74%. It is associated with high morbidity and mortality, being considered the third leading cause of death worldwide in 2021. Currently, spirometry represents the most standardized and well-known instrument for the diagnosis, control, and monitoring of COPD. However, the implementation of new tools is necessary to better define the characteristics of the disease and optimize its treatment. Furthermore, oscillometry is considered a quick and easy respiratory function test that allows the assessment of bronchial obstruction and emphysema by measuring pulmonary resistance and reactance, even in patients with normal spirometry. Its use in patients with asthma has allowed for comparisons of changes in airway obstruction with different inhaled corticosteroid (ICS) particles, with the aim of optimizing treatment choice. Therefore, its implementation in the study of patients diagnosed with COPD could also be very useful in this regard.
Main objective: To evaluate, using oscillometry, the therapeutic effectiveness of inhaled corticosteroids within triple closed therapy (LABA/LAMA/ICS) in a single device, compared to dual bronchodilation (LABA/LAMA), as maintenance treatment in patients with COPD exacerbators.
Methodology: This is an observational, prospective, multicenter study to be conducted in six hospitals in Catalonia, Spain. The goal is to include 63 patients diagnosed with COPD exacerbators, receiving dual bronchodilation treatment and meeting the endpoints for initiation of triple inhaled therapy, according to clinical practice guidelines (GesEPOC 2021, GOLD 2023). The device will be selected based on medical criteria, using the various closed-loop triple therapy inhalers currently available on the market. An initial oscillometry test will be performed to classify patients according to the predominant pattern: central obstruction, peripheral obstruction, and/or pulmonary hyperinflation. This initial measurement will be taken prior to changing treatment and immediately after the first dose of the new triple therapy inhaler. Subsequently, during patient follow-up, oscillometry will be repeated at 2, 4, and 12 weeks. The quality of life questionnaire (QLQ) and the inhaler adherence test will be self-administered at each visit. Data will be collected from the patients' electronic medical records and from laboratory tests performed during the previous year.
- Keywords
- Oscillometry, COPD, Inhaled corticosteroids
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Central bronchial obstruction | Oscillometry classification. | |
| Peripheral bronchial obstruction | Oscillometry classification. | |
| Pulmonary hyperinflation | Oscillometry classification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oscillometric results
R19, R5, R5-19, X19, X5, ∆Xrs (cmH2O/(L/s)
Measured: on each of the 3 visits (baseline, week 4, week 12)
Secondary outcomes (4)
Spirometric results
FVC, FEV1
Measured: initial and at visit 3 (baseline and week 12)
COPD Assessment Test (CAT)
score range 0-40, a higher score indicates a more severe impact of the disease on the patient's life.
Measured: on each of the 3 visits (baseline, week 4, week 12)
Test of Adherence of Inhalers (TAI)
Items 1 to 5 assess "erratic" non-compliance (score between 5 and 25); items 6 to 10 assess "deliberate" non-compliance (score between 5 and 25); items 11 and 12 assess "unconscious" non-compliance (score between 2 and 4).
Measured: on each of the 3 visits (baseline, week 4, week 12)
Spirometric results (forced expiratory volume in 1 second to forced vital capacity ratio)
FEV1/FVC
Measured: initial and at visit 3 (baseline and week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- 63 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Chiesi España, S.A.U.
- Responsible party
- Principal investigator, Yuliana Pascual González, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931899
- Sponsor's protocol ID
- EOM018/23
- Acronym
- OCTRIS
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient information can be viewed by study researchers through the REDCAP database, which has been previously coded.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Oscillometry in Assessing the Effectiveness of Inhaled Corticosteroides in Patients With COPD Exacerbator Phenotype
- ClinicalTrials.gov ID
- NCT06931899
- Acronym / sponsor ID
- OCTRIS / EOM018/23
- Keywords
- Oscillometry, COPD, Inhaled corticosteroids
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Chiesi España, S.A.U.
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Apr 2025 (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 objective of this observational study is to determine the effectiveness of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) and frequent worsening of their respiratory symptoms by using a device called an oscillometer. This instrument is capable of measuring bronchial obstruction and air trapping in the lungs through vibrations during normal breathing. The main question it seeks to answer is:
Could oscillometry be useful in assessing the effectiveness of inhaled corticosteroids in patients with COPD exacerbations, in terms of bronchial obstruction and air trapping in the lungs? Patients who choose to participate will undergo oscillometry testing and complete standard COPD questionnaires during three follow-up visits spread over three months.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the most prevalent chronic respiratory disease worldwide, estimated at around 12% in Spain and 17.3% in Catalonia, despite significant underdiagnosis of up to approximately 74%. It is associated with high morbidity and mortality, being considered the third leading cause of death worldwide in 2021. Currently, spirometry represents the most standardized and well-known instrument for the diagnosis, control, and monitoring of COPD. However, the implementation of new tools is necessary to better define the characteristics of the disease and optimize its treatment. Furthermore, oscillometry is considered a quick and easy respiratory function test that allows the assessment of bronchial obstruction and emphysema by measuring pulmonary resistance and reactance, even in patients with normal spirometry. Its use in patients with asthma has allowed for comparisons of changes in airway obstruction with different inhaled corticosteroid (ICS) particles, with the aim of optimizing treatment choice. Therefore, its implementation in the study of patients diagnosed with COPD could also be very useful in this regard.
Main objective: To evaluate, using oscillometry, the therapeutic effectiveness of inhaled corticosteroids within triple closed therapy (LABA/LAMA/ICS) in a single device, compared to dual bronchodilation (LABA/LAMA), as maintenance treatment in patients with COPD exacerbators.
Methodology: This is an observational, prospective, multicenter study to be conducted in six hospitals in Catalonia, Spain. The goal is to include 63 patients diagnosed with COPD exacerbators, receiving dual bronchodilation treatment and meeting the endpoints for initiation of triple inhaled therapy, according to clinical practice guidelines (GesEPOC 2021, GOLD 2023). The device will be selected based on medical criteria, using the various closed-loop triple therapy inhalers currently available on the market. An initial oscillometry test will be performed to classify patients according to the predominant pattern: central obstruction, peripheral obstruction, and/or pulmonary hyperinflation. This initial measurement will be taken prior to changing treatment and immediately after the first dose of the new triple therapy inhaler. Subsequently, during patient follow-up, oscillometry will be repeated at 2, 4, and 12 weeks. The quality of life questionnaire (QLQ) and the inhaler adherence test will be self-administered at each visit. Data will be collected from the patients' electronic medical records and from laboratory tests performed during the previous year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Central bronchial obstruction | – | –Oscillometry classification. |
| Peripheral bronchial obstruction | – | –Oscillometry classification. |
| Pulmonary hyperinflation | – | –Oscillometry classification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with exacerbating COPD from the pulmonology clinics of 6 hospitals in Catalonia, Spain.
Key inclusion criteria (7 listed)
- Age over 18 years.
- Diagnosis of COPD.
- Severe-moderate COPD measured by FEV1 and stable.
- Patient receiving dual bronchodilation therapy (LABA/LAMA) for at least the last 4 months prior to study inclusion and meeting clinical criteria to begin triple inhaled therapy.
- COPD exacerbations (COPD exacerbations).
Key exclusion criteria (8 listed)
- COPD in the last 4 weeks, with use of antibiotics or systemic corticosteroids.
- Chronic lung disease other than COPD.
- Severe heart failure, with frequent decompensation (in cases of mild decompensation or onset without severe heart disease, do not include the patient within 3 months of decompensation).
- Active neoplastic processes.
- Severe renal failure.
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
Oscillometric results
Time frame: on each of the 3 visits (baseline, week 4, week 12)
R19, R5, R5-19, X19, X5, ∆Xrs (cmH2O/(L/s)
4 secondary outcomes
Spirometric results
Time frame: initial and at visit 3 (baseline and week 12)
COPD Assessment Test (CAT)
Time frame: on each of the 3 visits (baseline, week 4, week 12)
Test of Adherence of Inhalers (TAI)
Time frame: on each of the 3 visits (baseline, week 4, week 12)
Spirometric results (forced expiratory volume in 1 second to forced vital capacity ratio)
Time frame: initial and at visit 3 (baseline and week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes. Patient information can be viewed by study researchers through the REDCAP database, which has been previously coded.
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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.
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 (Chronic Obstructive Pulmonary Disease), run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Apr 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuliana Pascual González, Pulmonology (PI) (0034937003626, ypascual@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oscillometric results (time frame: on each of the 3 visits (baseline, week 4, week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2025.