Pulmonary Disease, Chronic ObstructivePhase 3NCT01969721

Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

A Phase 3 study testing fluticasone propionate, salmeterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 29 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC [250/50µg and 500/50µg] delivered by the… 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?: fluticasone propionate, salmeterol and tiotropium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 229 participants
Where: 29 sitesin 8 countries
Study dates: Oct 2013to Feb 2015
Phase: Phase 3
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

Diagnosis of chronic obstructive pulmonary disease
Relatively stable airway obstruction with a post-bronchodilator 30% </= Forced Expiratory Volume in 1 second (FEV1)<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)FVC <70%
Male or female patients, 40 years of age or older
Smoking history of more than 10 pack years
Ability to perform technically acceptable pulmonary function tests and maintain records
Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)

Who cannot join

Significant disease other than COPD
COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
Clinically relevant abnormal lab values
History of asthma
Diagnosis of thyrotoxicosis
Diagnosis of paroxysmal tachycardia

Show all 23Show fewer

History of myocardial infarction
Unstable or life-threatening cardiac arrhythmia
Hospitalization for heart failure within the past year
Known active tuberculosis
malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
History of life-threatening pulmonary obstruction
History of cystic fibrosis
Clinically evident bronchiectasis
History of significant alcohol or drug abuse
History of thoracotomy with pulmonary resection
oral or patch ß-adrenergics
Oral corticosteroid medication within 6 weeks prior to Visit 1
Regular use daytime oxygen therapy for more than one hour per day
Pulmonary rehabilitation program in the six weeks prior to the screening visit
Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
Pregnant or nursing women

Trial locations and contacts

29 sites in 8 countries.

Country

City, postcode or hospital

29 sites in 8 countries

Netherlands6 sites

1237.11.31005 Boehringer Ingelheim Investigational Site
Almelo
1237.11.31002 Boehringer Ingelheim Investigational Site
Breda
1237.11.31006 Boehringer Ingelheim Investigational Site
Eindhoven
1237.11.31001 Boehringer Ingelheim Investigational Site
Heerlen
1237.11.31007 Boehringer Ingelheim Investigational Site
Hoorn
1237.11.31003 Boehringer Ingelheim Investigational Site
Zutphen

Other trials in Netherlands

Germany5 sites

1237.11.49003 Boehringer Ingelheim Investigational Site
Großhansdorf
1237.11.49005 Boehringer Ingelheim Investigational Site
Hamburg
1237.11.49001 Boehringer Ingelheim Investigational Site
Mannheim
1237.11.49004 Boehringer Ingelheim Investigational Site
Mönchengladbach
1237.11.49002 Boehringer Ingelheim Investigational Site
Wiesbaden

Other trials in Germany

Czechia4 sites

1237.11.42003 Boehringer Ingelheim Investigational Site
Kyjov
1237.11.42004 Boehringer Ingelheim Investigational Site
Rokycany
1237.11.42002 Boehringer Ingelheim Investigational Site
Tábor
1237.11.42001 Boehringer Ingelheim Investigational Site
Třebíč

Other trials in Czechia

Denmark4 sites

1237.11.45002 Boehringer Ingelheim Investigational Site
Hvidovre
1237.11.45004 Boehringer Ingelheim Investigational Site
Kolding
1237.11.45001 Boehringer Ingelheim Investigational Site
Odense C
1237.11.45003 Boehringer Ingelheim Investigational Site
Silkeborg

Other trials in Denmark

Hungary4 sites

1237.11.36001 Boehringer Ingelheim Investigational Site
Debrecen
1237.11.36004 Boehringer Ingelheim Investigational Site
Pécs
1237.11.36003 Boehringer Ingelheim Investigational Site
Szeged
1237.11.36002 Boehringer Ingelheim Investigational Site
Szombathely

Other trials in Hungary

Spain3 sites

1237.11.34003 Boehringer Ingelheim Investigational Site
Alicante
1237.11.34001 Boehringer Ingelheim Investigational Site
Barcelona
1237.11.34002 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón

Other trials in Spain

Belgium2 sites

1237.11.32002 Boehringer Ingelheim Investigational Site
Genk
1237.11.32001 Boehringer Ingelheim Investigational Site
Ghent

Other trials in Belgium

Sweden1 site

1237.11.46001 Boehringer Ingelheim Investigational Site
Lund

Other trials in Sweden

About this study

Official title: Randomized, Double-blind, Double-dummy, Active-controlled, 4 Period Complete Cross-over Study to Compare the Effect on Lung Function of 6 Weeks Once Daily Treatment With Orally Inhaled Tiotropium+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 6 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Accuhaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: fluticasone propionate, salmeterol, 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.

fluticasone propionateDrug
low dose
salmeterolDrug
placeboDrug
placebo/dummy for blinding purposes
placeboDrug
placebo/dummy for blinding purposes
tiotropiumDrug
tiotropium high dose
olodaterolDrug
olodaterolDrug
placeboDrug
placebo/dummy for blinding purposes
placeboDrug
placebo/dummy for blinding purposes
tiotropiumDrug
tiotropium low dose
fluticasone propionateDrug
low dose
salmeterolDrug

Study groups in NCT01969721
Study group	Role	What they receive
T+O FDC dosage 1	Experimental	Low dose Receives: Drug: olodaterol; Drug: placebo; Drug: tiotropium
T+O FDC dosage 2	Experimental	High dose Receives: Drug: placebo; Drug: tiotropium; Drug: olodaterol
ICS/LABA FDC Dosage 1	Active comparator	Low dose Receives: Drug: fluticasone propionate; Drug: salmeterol; Drug: placebo
ICS/LABA FDC Dosage 2	Active comparator	High dose Receives: Drug: placebo; Drug: fluticasone propionate; Drug: salmeterol

What is being measured

The primary outcome is the main question the study is designed to answer.

FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Measured: Baseline and 6 weeks.

Secondary outcomes (4)

FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.
Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Measured: Baseline and 6 weeks.
Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Measured: Baseline and 6 weeks.
FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.
The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Measured: Baseline and 6 weeks.
FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.
Measured: Baseline and 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Feb 2015

First posted25 Oct 2013 (estimated)
Study startOct 2013
Primary completionJan 2015
Study completionFeb 2015

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01969721
Sponsor's protocol ID: 1237.11
Other IDs: 2013-000808-41
Status last verified: Jan 2016
First submitted: 22 Oct 2013
Last updated: 12 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Double-dummy, Active-controlled, 4 Period Complete Cross-over Study to Compare the Effect on Lung Function of 6 Weeks Once Daily Treatment With Orally Inhaled Tiotropium+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 6 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Accuhaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01969721
Acronym / sponsor ID: 1237.11
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 25 Oct 2013 (estimated)
Results: Posted 12 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
T+O FDC dosage 1	Experimental	Drug: olodaterol, Drug: placebo, Drug: tiotropiumLow dose
T+O FDC dosage 2	Experimental	Drug: placebo, Drug: tiotropium, Drug: olodaterolHigh dose
ICS/LABA FDC Dosage 1	Active comparator	Drug: fluticasone propionate, Drug: salmeterol, Drug: placeboLow dose
ICS/LABA FDC Dosage 2	Active comparator	Drug: placebo, Drug: fluticasone propionate, Drug: salmeterolHigh dose

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of chronic obstructive pulmonary disease
Relatively stable airway obstruction with a post-bronchodilator 30% </= Forced Expiratory Volume in 1 second (FEV1)<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)FVC <70%
Male or female patients, 40 years of age or older
Smoking history of more than 10 pack years
Ability to perform technically acceptable pulmonary function tests and maintain records

Key exclusion criteria (23 listed)

Significant disease other than COPD
COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
Clinically relevant abnormal lab values
History of asthma
Diagnosis of thyrotoxicosis

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
fluticasone propionatelow dose	Drug	ICS/LABA FDC Dosage 1
salmeterol	Drug	ICS/LABA FDC Dosage 1
placeboplacebo/dummy for blinding purposes	Drug	T+O FDC dosage 2
placeboplacebo/dummy for blinding purposes	Drug	ICS/LABA FDC Dosage 2
tiotropiumtiotropium high dose	Drug	T+O FDC dosage 2
olodaterol	Drug	T+O FDC dosage 1
olodaterol	Drug	T+O FDC dosage 2
placeboplacebo/dummy for blinding purposes	Drug	T+O FDC dosage 1
placeboplacebo/dummy for blinding purposes	Drug	ICS/LABA FDC Dosage 1
tiotropiumtiotropium low dose	Drug	T+O FDC dosage 1
fluticasone propionatelow dose	Drug	ICS/LABA FDC Dosage 2
salmeterol	Drug	ICS/LABA FDC Dosage 2

Primary outcome

FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
Time frame: Baseline and 6 weeks.
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.

4 secondary outcomes

FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment
Time frame: Baseline and 6 weeks.
Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment
Time frame: Baseline and 6 weeks.
FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment
Time frame: Baseline and 6 weeks.
FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment
Time frame: Baseline and 6 weeks.

Results and safety

Results posted to the registry on 12 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T+O 2.5/5 / T+O 5/5 / F+S 250/50 / F+S 500/50	58	54
T+O 5/5 / F+S 500/50 / T+O 2.5/5 / F+S 250/50	69	57
F+S 250/50 / T+O 2.5/5 / F+S 500/50 / T+O 5/5	50	45
F+S 500/50 / F+S 250/50 / T+O 5/5 / T+O 2.5/5	52	46

Primary outcome: FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment

Time frame: Baseline and 6 weeks.. Mean (Standard Error). Unit: Litres

Measure	T+O 2.5/5 / F+S Placebo n = 214	T+O 5/5 / F+S Placebo n = 216	F+S 250/50 / T+O Placebo n = 211	F+S 500/50 / T+O Placebo n = 217
Value	0.295 (0.014)	0.317 (0.014)	0.192 (0.015)	0.188 (0.014)

T+O 5/5 / F+S Placebo vs F+S 250/50 / T+O Placebo: Mean Difference (Net): 0.125 (95% CI 0.103 to 0.147), p <0.0001, Mixed Models Analysis
T+O 5/5 / F+S Placebo vs F+S 500/50 / T+O Placebo: Mean Difference (Net): 0.129 (95% CI 0.107 to 0.150), p <0.0001, Mixed Models Analysis
T+O 2.5/5 / F+S Placebo vs F+S 250/50 / T+O Placebo: Mean Difference (Net): 0.103 (95% CI 0.081 to 0.124), p <0.0001, Mixed Models Analysis

Population analysed: FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug intake until 21 days after last drug intake, up to 88 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T+O 2.5/5 / F+S Placebo	6 of 215 (2.8%)	21 of 215 (9.8%)	Not reported
T+O 5/5 / F+S Placebo	7 of 221 (3.2%)	28 of 221 (12.7%)	Not reported
F+S 250/50 / T+O Placebo	4 of 212 (1.9%)	19 of 212 (9%)	Not reported
F+S 500/50 / T+O Placebo	9 of 219 (4.1%)	24 of 219 (11%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Disease, Chronic Obstructive

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.
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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

29 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluticasone propionate, salmeterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 29 sites in 8 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 23 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Netherlands, Germany, Czechia, Denmark, Hungary and 3 more countries. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2016). 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?

FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment (time frame: Baseline and 6 weeks.). 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 NCT01969721.

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 12 Feb 2016.