Characterization of 24 Hour Spirometry Profiles of Inhale... | NCT01040689

NCT01040689

ID	Type	Description	Link
2009-014417-27	EudraCT Number	EudraCT

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	olodaterol placebo and/or Tiotropium placebo inhaled once daily	Drug: Placebo (for olodaterol BI1744) Drug: Placebo (for Tiotropium)
Olodaterol (BI1744) Low	Experimental	Low dose inhaled orally once daily from Respimat inhaler	Drug: Olodaterol (BI1744) Low
Olodaterol (BI1744) High	Experimental	High dose inhaled orally once daily from Respimat inhaler	Drug: Olodaterol (BI1744) High
Tiotropium 18 mcg	Active Comparator	18mcg inhaled once daily from Handihaler	Drug: Tiotropium 18 mcg

Name	Type	Description	Arm Group Labels	Other Names
Olodaterol (BI1744) Low	Drug	Low dose inhaled orally once daily from Respimat inhaler	Olodaterol (BI1744) Low

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. 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.	1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h 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 for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. 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.	1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
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 first visit of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. 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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1222.39.32003 Boehringer Ingelheim Investigational Site		Genk			Belgium
1222.39.32001 Boehringer Ingelheim Investigational Site

References Module

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No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg	Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Study Total	Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 108 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 Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-0.054± 0.020 OG0010.131± 0.020 OG0020.152± 0.020 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.	<0.0001		Mean Difference (Final Values)	0.185	Standard Error of the Mean	0.020		95	0.145	0.224			Olo 5 mcg qd minus Placebo	No	Superiority or Other

Primary

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 for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. 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.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.

Secondary

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 first visit of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. 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.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.

Secondary

Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. 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.

FAS including all patients with evaluable data after first dose of treatment.

Posted

Mean

Standard Error

Liter

1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.

Secondary

Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.

Secondary

Peak FEV1 (0-3h) Response

Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.

FAS including all patients with evaluable data after first dose of treatment.

Posted

Mean

Standard Error

Liter

Study baseline and first day of dosing

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003	Tio 18 mcg qd	Tiotropium 18 mcg qd (morning) delivered by the HandiHaler

Secondary

Peak FEV1 (0-3h) Response

Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

Study baseline and 6 weeks

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003	Tio 18 mcg qd	Tiotropium 18 mcg qd (morning) delivered by the HandiHaler

Secondary

Trough FEV1 Response

Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of first treatment period. Trough values were the mean of values obtained 23 hours and 23h 50min post the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

Study baseline and 6 weeks

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003	Tio 18 mcg qd

Secondary

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 prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.

Secondary

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 prior to first dose of first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

1 h and 10 min prior to dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003

Secondary

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 prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment.

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.

Secondary

FVC Area Under Curve 0-3 Hours (AUC 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 prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

FAS including all patients with evaluable data after first dose of treatment.

Posted

Mean

Standard Error

Liter

1 hour (h) and 10 minutes (min) prior to dose on the first day of the treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003

Secondary

FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose after six weeks of treatment.

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003

Secondary

Peak FVC (0-3h) Response

Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose in first treatment period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

Study baseline and 6 weeks

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003	Tio 18 mcg qd	Tiotropium 18 mcg qd (morning) delivered by the HandiHaler

Secondary

Trough FVC Response

Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose in first treatment period. Trough values were mean of the values obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.

FAS including all patients with evaluable data after six weeks.

Posted

Mean

Standard Error

Liter

Study baseline and 6 weeks

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg qd	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg qd	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003	Tio 18 mcg qd	Tiotropium 18 mcg qd (morning) delivered by the HandiHaler

Secondary

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).

Treated set.

Posted

Number

percentage of participants

6 weeks

ID	Title	Description
OG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.
OG001	Olo 5 mcg	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
OG002	Olo 10 mcg	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
OG003	Tiotropium (Tio) 18 mcg qd	Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching Placebo delivered by the Respimat Inhaler or Handihaler.	5	102	12	102
EG001	Olo 5 mcg	Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.	1	101	14	101
EG002	Olo 10 mcg	Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.	0	101	6	101
EG003	Tiotropium (Tio) 18 mcg qd	Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler	5	101	10	101

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG0031 affected101 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0011 affected101 at risk EG0020 affected101 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Balanitis	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected102 at risk EG0010 affected101 at risk EG0020 affected101 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment		EG0008 affected102 at risk EG0016 affected101 at risk EG0024 affected101 at risk EG0037 affected101 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment		EG0004 affected102 at risk EG0018 affected101 at risk EG0022 affected101 at risk EG003

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C549647	olodaterol
D000069447	Tiotropium Bromide

Ancestor Terms

ID	Term
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D009930	Organic Chemicals
D000470	Alkaloids
D006571	Heterocyclic Compounds
D019086	Bridged Bicyclo Compounds, Heterocyclic
D006572	Heterocyclic Compounds, Bridged-Ring

Tiotropium 18 mcg qd (morning) delivered by the HandiHaler

Units	Counts
Participants	OG000102 OG001101 OG002101 OG003101