Pulmonary Disease, Chronic ObstructivePhase 4NCT02683109
Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
A Phase 4 study testing FDC of tiotropium + olodaterol, Tiotropium and Olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 22 sites in 5 countries.
Trial summary
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study. Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg… 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?
- FDC of tiotropium + olodaterol, Tiotropium and Olodaterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 8 Mar 2016to 30 Jan 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or female patients.
- Patients 40 years of age or older.
- Patients with a smoking history > 10 pack years.
- Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening.
- Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.
- Further inclusion criteria apply.
Who cannot join
- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- Patients with a current diagnosis of asthma.
- Further exclusion criteria apply.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
France9 sites
HOP Louis Pradel
Bron, 69677
CLI du Parc, Pneumo, Castelnau le Lez
Castelnau-le-Lez, 34170
CAB Pigearias B., Pneumo, Nice
Nice, 06000
CAB Dupouy J, Pneumo, Nîmes
Nîmes, 30900
HOP Cochin
Paris, 75014
HOP Haut-Lévêque
Pessac, 33604
HOP Maison Blanche
Reims, 51092
INS A.Tzanck,Pneumo,St Laurent du Var
Saint-Laurent-du-Var, 06721
CAB Lejay D, MG, Vieux Condé
Vieux-Condé, 59690
Finland5 sites
Jorvin sairaala
Espoo, FI-02740
HYKS Keuhkosairauksien
Helsinki, 00029
TAYS, Keuhkotautien poliklinikka
Tampere, FI-33520
TYKS, Keuhkosairauksien klinikka, Turku
Turku, 20520
Terveystalo Pulssi, Turku
Turku, FI-20100
Denmark3 sites
Aarhus Universitetshospital
Aarhus, 8000
Hvidovre Hospital
Hvidovre, 2650
Regionshospitalet Silkeborg
Silkeborg, 8600
Slovenia3 sites
Univ. Clinic of Respiratory and Allergic Diseases, Golnik
Golnik, 4204
Verboten Kopriva Renata - Private practice, Litija
Litija, 1270
Arjana Macek d.o.o.
Ljubljana, 1000
Austria2 sites
Ordination Dr. Robert Voves, 8330 Feldbach
Feldbach, 8330
KH d. Elisabethinen Linz
Linz, 4020
About this study
Official title: A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- FDC of tiotropium + olodaterol, Placebo, Tiotropium, Olodaterol
- 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.
FDC of tiotropium + olodaterolDrug
Fixed Dose Combination of tiotropium + olodaterol
PlaceboDrug
TiotropiumDrug
OlodaterolDrug
| Study group | Role | What they receive |
|---|---|---|
| FDC of tiotropium + olodaterol | Experimental | Fixed Dose Combination of tiotropium + olodaterol Receives: Drug: FDC of tiotropium + olodaterol; Drug: Placebo |
| Free combination tiotropium + olodaterol | Active comparator | Not described Receives: Drug: Tiotropium; Drug: Olodaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5.
The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
Measured: Day 29
Secondary outcomes (2)
Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment
This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29).
The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC.
Measured: Day 29
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28
This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health).
The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start8 Mar 2016
- Primary completion9 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683109
- Sponsor's protocol ID
- 1237.49
- Other IDs
- 2015-003879-29, 2015
- Status last verified
- Dec 2017
- First submitted
- 12 Feb 2016
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02683109
- Acronym / sponsor ID
- 1237.49
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 17 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDC of tiotropium + olodaterol | Experimental | Drug: FDC of tiotropium + olodaterol, Drug: PlaceboFixed Dose Combination of tiotropium + olodaterol |
| Free combination tiotropium + olodaterol | Active comparator | Drug: Tiotropium, Drug: Olodaterol |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients.
- Patients 40 years of age or older.
- Patients with a smoking history > 10 pack years.
- Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening.
- Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.
Key exclusion criteria (3 listed)
- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- Patients with a current diagnosis of asthma.
- Further exclusion criteria apply.
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 |
|---|---|---|
| FDC of tiotropium + olodaterolFixed Dose Combination of tiotropium + olodaterol | Drug | FDC of tiotropium + olodaterol |
| Placebo | Drug | FDC of tiotropium + olodaterol |
| Tiotropium | Drug | Free combination tiotropium + olodaterol |
| Olodaterol | Drug | Free combination tiotropium + olodaterol |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
Time frame: Day 29
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
2 secondary outcomes
Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment
Time frame: Day 29
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FDC of tiotropium + olodaterol, Tiotropium and Olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 22 sites in 5 countries.
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 3 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Finland, Denmark, Slovenia, Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment (time frame: Day 29). 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 Aug 2018.