Trial Outcomes & Findings for Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease (NCT NCT00931385)

NCT ID: NCT00931385

Last Updated: 2014-07-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 99 participants
• Primary outcome timeframe: 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
• Results posted on: 2014-07-01

Participant Flow

This was a randomised, double-blind, double-dummy, placebo-controlled, 4-way crossover trial. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.

Participant milestones

Measure	Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg Patients were administered Olodaterol 5 mcg qd in the first period, Foradil 12 mcg bid in the second period, matching Placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.	Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and matching Placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.	Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg Patients were administered Olodaterol 10 mcg qd in the first period, matching Placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.	Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg Patients were administered matching Placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
Overall Study STARTED	25	23	25	26
Overall Study COMPLETED	23	21	24	21
Overall Study NOT COMPLETED	2	2	1	5

Reasons for withdrawal

Measure	Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg Patients were administered Olodaterol 5 mcg qd in the first period, Foradil 12 mcg bid in the second period, matching Placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.	Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and matching Placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.	Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg Patients were administered Olodaterol 10 mcg qd in the first period, matching Placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.	Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg Patients were administered matching Placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
Overall Study Adverse Event	2	1	0	3
Overall Study Protocol Violation	0	0	1	0
Overall Study Withdrawal by Subject	0	1	0	1
Overall Study Lost to Follow-up	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Study Total n=99 Participants Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
Age, Continuous	61.8 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment	-0.060 Liter Standard Error 0.020	0.088 Liter Standard Error 0.021	0.088 Liter Standard Error 0.021	0.081 Liter Standard Error 0.021

PRIMARY outcome

Timeframe: 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

Population: FAS

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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment	-0.123 Liter Standard Error 0.021	-0.014 Liter Standard Error 0.022	0.004 Liter Standard Error 0.022	0.049 Liter Standard Error 0.022

SECONDARY outcome

Timeframe: 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.

Population: FAS

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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment	-0.092 Liter Standard Error 0.020	0.037 Liter Standard Error 0.021	0.046 Liter Standard Error 0.021	0.065 Liter Standard Error 0.021

SECONDARY outcome

Timeframe: 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 the last am dose after six weeks of treatment

Population: FAS

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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment	-0.030 Liter Standard Error 0.020	0.134 Liter Standard Error 0.021	0.135 Liter Standard Error 0.021	0.168 Liter Standard Error 0.021

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: FAS

Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit. Peak (0-3h) 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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Peak FEV1 (0-3h) Response	0.034 Liter Standard Error 0.022	0.208 Liter Standard Error 0.022	0.200 Liter Standard Error 0.022	0.251 Liter Standard Error 0.022

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: FAS

Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough 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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Trough FEV1 Response	-0.093 Liter Standard Error 0.023	0.012 Liter Standard Error 0.024	0.020 Liter Standard Error 0.024	0.040 Liter Standard Error 0.024

SECONDARY outcome

Timeframe: 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

Population: FAS

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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response	-0.086 Liter Standard Error 0.036	0.139 Liter Standard Error 0.036	0.142 Liter Standard Error 0.036	0.117 Liter Standard Error 0.036

SECONDARY outcome

Timeframe: 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

Population: FAS

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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response	-0.164 Liter Standard Error 0.036	-0.016 Liter Standard Error 0.037	0.008 Liter Standard Error 0.037	0.088 Liter Standard Error 0.037

SECONDARY outcome

Timeframe: 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.

Population: FAS

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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response	-0.125 Liter Standard Error 0.035	0.061 Liter Standard Error 0.035	0.075 Liter Standard Error 0.035	0.102 Liter Standard Error 0.035

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: FAS

Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit. Peak FVC (0-3h) 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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Peak FVC (0-3h) Response	0.107 Liter Standard Error 0.038	0.368 Liter Standard Error 0.039	0.360 Liter Standard Error 0.039	0.410 Liter Standard Error 0.039

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: FAS

Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough 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.

Outcome measures

Measure	Placebo n=93 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=92 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=91 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=90 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Trough FVC Response	-0.117 Liter Standard Error 0.039	0.037 Liter Standard Error 0.040	0.037 Liter Standard Error 0.040	0.066 Liter Standard Error 0.040

SECONDARY outcome

Timeframe: 6 weeks

Population: Treated set.

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).

Outcome measures

Measure	Placebo n=96 Participants Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.	Olo 5 mcg qd n=95 Participants Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg qd n=92 Participants Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg Bid n=93 Participants Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG Heart rate increased	0 participants	1 participants	0 participants	0 participants
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG Tachycardia	0 participants	0 participants	1 participants	0 participants

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Olo 5 mcg

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Olo 10 mcg

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Form 12 mcg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=96 participants at risk Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.	Olo 5 mcg n=95 participants at risk Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg n=92 participants at risk Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg n=93 participants at risk Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Cardiac disorders Atrial fibrillation	1.0% 1/96 • 6 weeks	0.00% 0/95 • 6 weeks	0.00% 0/92 • 6 weeks	0.00% 0/93 • 6 weeks
Cardiac disorders Cardio-respiratory arrest	0.00% 0/96 • 6 weeks	1.1% 1/95 • 6 weeks	0.00% 0/92 • 6 weeks	0.00% 0/93 • 6 weeks
Cardiac disorders Myocardial infarction	0.00% 0/96 • 6 weeks	0.00% 0/95 • 6 weeks	1.1% 1/92 • 6 weeks	1.1% 1/93 • 6 weeks
Infections and infestations Pneumonia	0.00% 0/96 • 6 weeks	1.1% 1/95 • 6 weeks	0.00% 0/92 • 6 weeks	0.00% 0/93 • 6 weeks
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/96 • 6 weeks	0.00% 0/95 • 6 weeks	1.1% 1/92 • 6 weeks	0.00% 0/93 • 6 weeks
Nervous system disorders Cerebrovascular accident	1.0% 1/96 • 6 weeks	0.00% 0/95 • 6 weeks	0.00% 0/92 • 6 weeks	0.00% 0/93 • 6 weeks
Nervous system disorders Radiculopathy	0.00% 0/96 • 6 weeks	0.00% 0/95 • 6 weeks	1.1% 1/92 • 6 weeks	0.00% 0/93 • 6 weeks
Psychiatric disorders Depression	0.00% 0/96 • 6 weeks	1.1% 1/95 • 6 weeks	0.00% 0/92 • 6 weeks	0.00% 0/93 • 6 weeks
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.1% 2/96 • 6 weeks	1.1% 1/95 • 6 weeks	0.00% 0/92 • 6 weeks	1.1% 1/93 • 6 weeks

Other adverse events

Measure	Placebo n=96 participants at risk Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.	Olo 5 mcg n=95 participants at risk Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	Olo 10 mcg n=92 participants at risk Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	Form 12 mcg n=93 participants at risk Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.2% 5/96 • 6 weeks	4.2% 4/95 • 6 weeks	1.1% 1/92 • 6 weeks	3.2% 3/93 • 6 weeks

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication
• Publication restrictions are in place

Restriction type: OTHER