Pulmonary Disease, Chronic ObstructiveNCT04402515
Tiotropium Plus Olodaterol vs Inhaled Corticosteroids (ICS) Regimens in the Portuguese Primary Care Setting (TIOLCOR Study)
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
What are the differences between patients prescribed a new maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics? Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- TIO/OLO and ICS
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2021to 31 Jan 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The source population are COPD patients starting a new maintenance COPD treatment with TIO/OLO or with an ICS-containing regimen in the primary care setting.
Who may be able to join
- Aged ≥ 40 years at the date of COPD diagnosis.
- Diagnosis of COPD confirmed by the investigator. A spirometry confirming the diagnosis (FEV1/forced vital capacity [FVC] ratio <0.7) and performed within the three years prior to the inclusion visit must be available in the patient's medical records.
- Prescription of a new maintenance COPD treatment with TIO/OLO or ICS-containing regimens (not including TIO/OLO) 3 months (-7/+30 days) prior to the inclusion visit. The COPD treatment may have been prescribed at primary care sites or at the hospital.
- Written informed consent prior to participation.
Who cannot join
- 1. Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to or at the index date).
- 2a. For treatment naïve patients (i.e., those who have never started a maintenance therapy for COPD [with either short- or long-acting bronchodilators or ICS]) - no data on the GOLD 2019 group at the index date is available in the medical records. Patients may still be included if the determination of the GOLD 2019 group is possible based on the medical records' data and/or patient interviews (e.g. by using information on exacerbation history in the 12 months prior to the index date, and data on mMRC and COPD Assessment Test (CAT) at the index date).
- 2b. For treatment experienced patients - no data on the predominant treatable trait to target at the index date (dyspnea, exacerbation or both) is available in the medical records. Patients may still be included if this information is obtained based on patient interviews.
- 3. Participation in a clinical trial within the 3 months prior to the inclusion visit.
About this study
Official title: Preferences and Consequences in Therapy Decision-making: Tiotropium Bromide Plus Olodaterol vs ICS-containing Regimens in COPD Patients in the Portuguese Primary Care Setting: an Observational, Cross-sectional Study
What are the differences between patients prescribed a new maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics?
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- TIO/OLO, ICS
- 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.
TIO/OLODrug
Tiotropium/Olodaterol
ICSDrug
inhaled cortocosteroids
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium plus Olodaterol treatment regimen | Not described Receives: Drug: TIO/OLO | |
| Inhaled corticosteroids-containing treatment regimen | Not described Receives: Drug: ICS |
What is being measured
The primary outcome is the main question the study is designed to answer.
N of patients by education level
Measured: up to 4 months
smoking status
Measured: up to 4 months
BMI
Measured: up to 4 months
N of patients by Portugal region
regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II)
Measured: up to 4 months
year of COPD diagnosis
Measured: up to 4 months
comorbidities
Measured: up to 4 months
GOLD 2019 group assessment
Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D
Measured: up to 4 months
GOLD 2019 grade
Global Initiative for Chronic Obstructive Lung Disease; grades 1-4
Measured: up to 4 months
blood eosinophil count
Measured: up to 4 months
post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio
FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity
Measured: up to 4 months
FEV1 % predicted
Measured: up to 4 months
number of COPD exacerbations
Measured: in the 12 months prior to the index date
N of patients with pneumonia
Measured: up to 4 months
Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire
Measured: up to 4 months
CAT score
CAT: COPD Assessment Test
Measured: up to 4 months
Setting in which the COPD treatment was prescribed
primary vs. hospital
Measured: up to 4 months
Reasons for COPD treatment change
Index date is the prescription date of the new or initial COPD maintenance treatment.
Measured: Index date
Reasons for COPD treatment change between the index date and the inclusion visit
Measured: up to 4 months
Secondary outcomes (4)
Number of patients for whom the new COPD treatment is in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Guideline recommendations
Index date is the prescription date of the new or initial COPD maintenance treatment.
Measured: Index date
Patient Quality of Life according to EQ-5D-5L questionnaire
Measured: up to 4 months
Overall patient satisfaction with inhaler device according to a 5-point Likert scale
Measured: up to 4 months
Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start28 Oct 2021 (estimated)
- Primary completion15 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Why it stopped: not due to safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402515
- Sponsor's protocol ID
- 1237-0096
- Status last verified
- Nov 2021
- First submitted
- 5 May 2020
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferences and Consequences in Therapy Decision-making: Tiotropium Bromide Plus Olodaterol vs ICS-containing Regimens in COPD Patients in the Portuguese Primary Care Setting: an Observational, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04402515
- Acronym / sponsor ID
- 1237-0096
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: not due to safety reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (estimated)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 27 May 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.
What are the differences between patients prescribed a new maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium plus Olodaterol treatment regimen | – | Drug: TIO/OLO |
| Inhaled corticosteroids-containing treatment regimen | – | Drug: ICS |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population are COPD patients starting a new maintenance COPD treatment with TIO/OLO or with an ICS-containing regimen in the primary care setting.
Key inclusion criteria (4 listed)
- Aged ≥ 40 years at the date of COPD diagnosis.
- Diagnosis of COPD confirmed by the investigator. A spirometry confirming the diagnosis (FEV1/forced vital capacity [FVC] ratio <0.7) and performed within the three years prior to the inclusion visit must be available in the patient's medical records.
- Prescription of a new maintenance COPD treatment with TIO/OLO or ICS-containing regimens (not including TIO/OLO) 3 months (-7/+30 days) prior to the inclusion visit. The COPD treatment may have been prescribed at primary care sites or at the hospital.
- Written informed consent prior to participation.
Key exclusion criteria (4 listed)
- 1. Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to or at the index date).
- 2a. For treatment naïve patients (i.e., those who have never started a maintenance therapy for COPD [with either short- or long-acting bronchodilators or ICS]) - no data on the GOLD 2019 group at the index date is available in the medical records. Patients may still be included if the determination of the GOLD 2019 group is possible based on the medical records' data and/or patient interviews (e.g. by using information on exacerbation history in the 12 months prior to the index date, and data on mMRC and COPD Assessment Test (CAT) at the index date).
- 2b. For treatment experienced patients - no data on the predominant treatable trait to target at the index date (dyspnea, exacerbation or both) is available in the medical records. Patients may still be included if this information is obtained based on patient interviews.
- 3. Participation in a clinical trial within the 3 months prior to the inclusion visit.
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 |
|---|---|---|
| TIO/OLOTiotropium/Olodaterol | Drug | Tiotropium plus Olodaterol treatment regimen |
| ICSinhaled cortocosteroids | Drug | Inhaled corticosteroids-containing treatment regimen |
Primary outcome
N of patients by education level
Time frame: up to 4 months
smoking status
Time frame: up to 4 months
BMI
Time frame: up to 4 months
N of patients by Portugal region
Time frame: up to 4 months
regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II)
year of COPD diagnosis
Time frame: up to 4 months
comorbidities
Time frame: up to 4 months
GOLD 2019 group assessment
Time frame: up to 4 months
Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D
GOLD 2019 grade
Time frame: up to 4 months
Global Initiative for Chronic Obstructive Lung Disease; grades 1-4
blood eosinophil count
Time frame: up to 4 months
post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio
Time frame: up to 4 months
FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity
FEV1 % predicted
Time frame: up to 4 months
number of COPD exacerbations
Time frame: in the 12 months prior to the index date
N of patients with pneumonia
Time frame: up to 4 months
Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire
Time frame: up to 4 months
CAT score
Time frame: up to 4 months
CAT: COPD Assessment Test
Setting in which the COPD treatment was prescribed
Time frame: up to 4 months
primary vs. hospital
Reasons for COPD treatment change
Time frame: Index date
Index date is the prescription date of the new or initial COPD maintenance treatment.
Reasons for COPD treatment change between the index date and the inclusion visit
Time frame: up to 4 months
4 secondary outcomes
Number of patients for whom the new COPD treatment is in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Guideline recommendations
Time frame: Index date
Patient Quality of Life according to EQ-5D-5L questionnaire
Time frame: up to 4 months
Overall patient satisfaction with inhaler device according to a 5-point Likert scale
Time frame: up to 4 months
Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication
Time frame: up to 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 4 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: withdrawn, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
N of patients by education level (time frame: up to 4 months). The study lists 18 primary outcomes in all. 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 5 Nov 2021.