Pulmonary Disease, Chronic ObstructivePhase 3NCT00932646

Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing BI 1744 (Olodaterol) Low Dose, BI 1744 (Olodaterol) Medium Dose and Foradil in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 13 sites in United States.

Completed

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

Official record

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Trial summary

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments. 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?: BI 1744 (Olodaterol) Low Dose, BI 1744 (Olodaterol) Medium Dose and Foradil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 13 sitesUnited States
Study dates: Jun 2009to May 2010
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

Patients willing to participate with confirmed diagnosis of COPD
40 years of age or older
having a 10 pack year smoking history
able to perform serial pulmonary function tests
able to use both a DPI and Respimat device

Who cannot join

Significant other disease
clinically relevant abnormal hematology, chemistry, or urinalysis
history of asthma
diagnosis of thyrotoxicosis
paroxysmal tachycardia related to beta agonists
history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year

Show all 16Show fewer

active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
significant alcohol or drug use
pulmonary resection
taking oral beta adrenergics
taking unstable oral steroids
daytime oxygen
enrolled in rehabilitation program
enrolled in another study or taking investigational products
pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
those who are not willing to comply with pulmonary medication washouts

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

1222.25.25008 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1222.25.25010 Boehringer Ingelheim Investigational Site
Austell, Georgia
1222.25.25012 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1222.25.25002 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1222.25.25011 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1222.25.25003 Boehringer Ingelheim Investigational Site
DeLand, Florida
1222.25.25005 Boehringer Ingelheim Investigational Site
Houston, Texas
1222.25.25009 Boehringer Ingelheim Investigational Site
Jasper, Alabama
1222.25.25006 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
1222.25.25004 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1222.25.25013 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1222.25.25014 Boehringer Ingelheim Investigational Site
Seneca, South Carolina
1222.25.25007 Boehringer Ingelheim Investigational Site
Winter Park, Florida

Other trials in United States

About this study

Official title: Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: BI 1744 (Olodaterol) Low Dose, BI 1744 (Olodaterol) Medium Dose, Placebo, Foradil
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.

BI 1744 (Olodaterol) Low DoseDrug
BI1744 Respimat low dose once daily and placebo Foradil
BI 1744 (Olodaterol) Medium DoseDrug
BI1744 Respimat medium dose once daily and placebo Foradil
PlaceboDrug
Placebo Respimat once daily and placebo Foradil
ForadilDrug
12 mcg twice daily and placebo Respimat

Study groups in NCT00932646
Study group	Role	What they receive
BI1744 (Olodaterol)	Experimental	Medium Dose once Daily Receives: Drug: BI 1744 (Olodaterol) Medium Dose
BI 1744 (Olodaterol)	Experimental	Low Dose once Daily Receives: Drug: BI 1744 (Olodaterol) Low Dose
Placebo	Placebo comparator	Placebo once Daily Receives: Drug: Placebo
Foradil	Active comparator	12 mcg twice daily Receives: Drug: Foradil

What is being measured

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

FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Measured: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment
FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Measured: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment

Secondary outcomes (10)

Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
Measured: 1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.
Measured: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment
Peak FEV1 (0-3h) Response
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
Measured: Baseline and 6 weeks
Trough FEV1 Response
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
Measured: Baseline and 6 weeks
Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Measured: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment
FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Measured: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Measured: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.
Peak FVC (0-3h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
Measured: Baseline and 6 weeks
Trough FVC Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
Measured: Baseline and 6 weeks
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
Measured: 6 weeks

Timeline

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

Jun 2009May 2010

First posted3 Jul 2009 (estimated)
Study startJun 2009
Primary completionMay 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00932646
Sponsor's protocol ID: 1222.25
Status last verified: Jan 2016
First submitted: 2 Jul 2009
Last updated: 5 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Feldman GJ, Bernstein JA, Hamilton A, Nivens MC, Korducki L, LaForce C. The 24-h FEV1 time profile of olodaterol once daily via Respimat(R) and formoterol twice daily via Aerolizer(R) in patients with GOLD 2-4 COPD: results from two 6-week crossover studies. Springerplus. 2014 Aug 9;3:419. doi: 10.1186/2193-1801-3-419. eCollection 2014.
PubMed 25187881

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 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT00932646
Acronym / sponsor ID: 1222.25
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: May 2010 (actual)
First posted: 3 Jul 2009 (estimated)
Results: Posted 27 Jun 2014

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
BI1744 (Olodaterol)	Experimental	Drug: BI 1744 (Olodaterol) Medium DoseMedium Dose once Daily
BI 1744 (Olodaterol)	Experimental	Drug: BI 1744 (Olodaterol) Low DoseLow Dose once Daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo once Daily
Foradil	Active comparator	Drug: Foradil12 mcg twice daily

Who may qualify

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

Key inclusion criteria (5 listed)

Patients willing to participate with confirmed diagnosis of COPD
40 years of age or older
having a 10 pack year smoking history
able to perform serial pulmonary function tests
able to use both a DPI and Respimat device

Key exclusion criteria (16 listed)

Significant other disease
clinically relevant abnormal hematology, chemistry, or urinalysis
history of asthma
diagnosis of thyrotoxicosis
paroxysmal tachycardia related to beta agonists

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
BI 1744 (Olodaterol) Low DoseBI1744 Respimat low dose once daily and placebo Foradil	Drug	BI 1744 (Olodaterol)
BI 1744 (Olodaterol) Medium DoseBI1744 Respimat medium dose once daily and placebo Foradil	Drug	BI1744 (Olodaterol)
PlaceboPlacebo Respimat once daily and placebo Foradil	Drug	Placebo
Foradil12 mcg twice daily and placebo Respimat	Drug	Foradil

Primary outcome

FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
Time frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment
Time frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

10 secondary outcomes

Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment
Time frame: 1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment
Time frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment
Peak FEV1 (0-3h) Response
Time frame: Baseline and 6 weeks
Trough FEV1 Response
Time frame: Baseline and 6 weeks
Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
Time frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment
FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
Time frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
Time frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.
Peak FVC (0-3h) Response
Time frame: Baseline and 6 weeks
Trough FVC Response
Time frame: Baseline and 6 weeks
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Time frame: 6 weeks

Results and safety

Results posted to the registry on 27 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg	25	20
Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg	25	22
Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg	25	21
Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo	25	24

Primary outcome: FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment

Time frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment. Least squares mean (Standard Error). Unit: Liter

Measure	Placebo n = 91	Olo 5 mcg qd n = 92	Olo 10 mcg qd n = 90	Form 12 mcg Bid n = 90
Value	-0.022 (0.024)	0.150 (0.024)	0.152 (0.024)	0.136 (0.024)

Placebo vs Olo 5 mcg qd: Mean Difference (Final Values): 0.172 (95% CI 0.139 to 0.205), p <0.0001, Mixed Models Analysis
Placebo vs Olo 10 mcg qd: Mean Difference (Final Values): 0.174 (95% CI 0.140 to 0.208), p <0.0001, Mixed Models Analysis
Placebo vs Form 12 mcg Bid: Mean Difference (Final Values): 0.158 (95% CI 0.124 to 0.191), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) date and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.

Primary outcome: FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment

Time frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment. Least squares mean (Standard Error). Unit: Liter

Measure	Placebo n = 91	Olo 5 mcg qd n = 92	Olo 10 mcg qd n = 90	Form 12 mcg Bid n = 90
Value	-0.048 (0.025)	0.069 (0.025)	0.072 (0.025)	0.107 (0.025)

Placebo vs Olo 5 mcg qd: Mean Difference (Final Values): 0.118 (95% CI 0.082 to 0.154), p <0.0001, Mixed Models Analysis
Placebo vs Olo 10 mcg qd: Mean Difference (Final Values): 0.120 (95% CI 0.084 to 0.157), p <0.0001, Mixed Models Analysis
Placebo vs Form 12 mcg Bid: Mean Difference (Final Values): 0.155 (95% CI 0.119 to 0.191), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set (FAS).

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 94 (3.2%)	9 of 94 (9.6%)	Not reported
Olo 5 mcg	4 of 93 (4.3%)	9 of 93 (9.7%)	Not reported
Olo 10 mcg	3 of 95 (3.2%)	12 of 95 (12.6%)	Not reported
Form 12 mcg	5 of 93 (5.4%)	7 of 93 (7.5%)	Not reported

Limitations and caveats (from the sponsor): 1. Safety assessments are potentially confounded by both crossover and long washout periods 2. Comparisons of active groups for the 12 to 24 hr period overestimate the effect of Foradil (sleeping period causing an overestimation of AUC)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25187881Feldman GJ, Bernstein JA, Hamilton A, Nivens MC, Korducki L, LaForce C. The 24-h FEV1 time profile of olodaterol once daily via Respimat(R) and formoterol twice daily via Aerolizer(R) in patients with GOLD 2-4 COPD: results from two 6-week crossover studies. Springerplus. 2014 Aug 9;3:419. doi: 10.1186/2193-1801-3-419. eCollection 2014.
Related InfoLink provided by the sponsor.

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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

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 16 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 5 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 13 sites in United States. 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. Some participants in this study may receive a placebo. 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 27 Jun 2014). 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 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment (time frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment). The study lists 2 primary outcomes in all. 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 NCT00932646, which also lists 1 linked publication.

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 Feb 2016.