Trial Outcomes & Findings for Tiotropium / Respimat One Year Study in COPD. (NCT NCT00387088)

Last Updated: 2014-05-16

Results Overview

Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3991 participants

Primary outcome timeframe

Baseline and Day 337

Results posted on

2014-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Tiotropium Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Study STARTED	1989	2002
Overall Study COMPLETED	1671	1629
Overall Study NOT COMPLETED	318	373

Reasons for withdrawal

Reasons for withdrawal
Measure	Tiotropium Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Overall Study Adverse Event	143	156
Overall Study Protocol Violation	47	35
Overall Study Withdrawal by Subject	20	35
Overall Study Lack of Efficacy	28	67
Overall Study Lost to Follow-up	22	28
Overall Study Other	58	52

Baseline Characteristics

Tiotropium / Respimat One Year Study in COPD.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tiotropium n=1952 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1965 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Total n=3917 Participants Total of all reporting groups
Age, Continuous	64.8 Years STANDARD_DEVIATION 9.1 • n=5 Participants	64.8 Years STANDARD_DEVIATION 9 • n=7 Participants	64.80 Years STANDARD_DEVIATION 9.00 • n=5 Participants
Sex: Female, Male Female	428 Participants n=5 Participants	452 Participants n=7 Participants	880 Participants n=5 Participants
Sex: Female, Male Male	1524 Participants n=5 Participants	1513 Participants n=7 Participants	3037 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 337

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.

Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).

Outcome measures

Outcome measures
Measure	Tiotropium n=1889 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1870 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337	0.119 Litres Standard Error 0.007	0.018 Litres Standard Error 0.007

PRIMARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation	NA Days As \<50% of the patients experienced an exacerbation in both treatment groups the median and 95% confidence interval were not estimable. Refer to the secondary endpoint 'Number of patients with at least one COPD exacerbation' for further information.	NA Days Interval 354.0 to As \<50% of the patients experienced an exacerbation in both treatment groups the median and 95% confidence interval were not estimable. Refer to the secondary endpoint 'Number of patients with at least one COPD exacerbation' for further information.

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data.

Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

Outcome measures

Outcome measures
Measure	Tiotropium n=1879 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1866 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29	0.11 Litres Standard Error 0.005	0.017 Litres Standard Error 0.005

SECONDARY outcome

Timeframe: Baseline and Day 169

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.

Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

Outcome measures

Outcome measures
Measure	Tiotropium n=1889 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1870 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169	0.121 Litres Standard Error 0.006	0.018 Litres Standard Error 0.006

SECONDARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Number of COPD Exacerbations Per Patient - Exposure Adjusted	0 COPD exacerbations per year Full Range 0 • Interval 0.0 to 21.5	0 COPD exacerbations per year Full Range 0 • Interval 0.0 to 182.6

SECONDARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Number of COPD Exacerbations Per Patient - naïve Estimate	0 COPD exacerbations Full Range 0 • Interval 0.0 to 9.0	0 COPD exacerbations Full Range 0 • Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Number of Patients With at Least One COPD Exacerbation	685 participants	842 participants

SECONDARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Time to First Hospitalisation for COPD Exacerbation	NA Days As \<50% of the patients experienced an exacerbation in both treatment groups the median and 95% confidence interval were not estimable. Refer to the secondary endpoint 'Number of patients with at least one COPD exacerbation' for further information.	NA Days As \<50% of the patients experienced an exacerbation in both treatment groups the median and 95% confidence interval were not estimable. Refer to the secondary endpoint 'Number of patients with at least one COPD exacerbation' for further information.

SECONDARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted	0 hospitalisations for COPD exacerbations Full Range 0 • Interval 0.0 to 21.5	0 hospitalisations for COPD exacerbations Full Range 0 • Interval 0.0 to 91.3

SECONDARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate	0 hospitalisations for COPD exacerbations Full Range 0 • Interval 0.0 to 5.0	0 hospitalisations for COPD exacerbations Full Range 0 • Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: During actual study treatment period (planned Day 1 to Day 337)

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation	161 participants	198 participants

SECONDARY outcome

Timeframe: Baseline and Day 337

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.

The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

Outcome measures

Outcome measures
Measure	Tiotropium n=1690 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1668 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337	-4.726 Units on a scale Standard Error 0.372	-1.787 Units on a scale Standard Error 0.374

SECONDARY outcome

Timeframe: Baseline and Day 169

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.

The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

Outcome measures

Outcome measures
Measure	Tiotropium n=1690 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1668 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169	-4.764 Units on a scale Standard Error 0.348	-2.568 Units on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline and Day 337

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.

The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 Symptoms (N=1704,1688)	-7.260 Units on a scale Standard Error 0.546	-3.307 Units on a scale Standard Error 0.548
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 Activities (N=1690,1668)	-3.196 Units on a scale Standard Error 0.456	-0.226 Units on a scale Standard Error 0.460
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 Impacts (N=1690,1668)	-4.873 Units on a scale Standard Error 0.409	-2.038 Units on a scale Standard Error 0.412

SECONDARY outcome

Timeframe: Baseline and Day 169

The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

Outcome measures

Outcome measures
Measure	Tiotropium n=1939 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1953 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 Activities (N=1690,1668)	-3.573 Units on a scale Standard Error 0.432	-1.218 Units on a scale Standard Error 0.435
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 Impacts (N=1690,1668)	-4.917 Units on a scale Standard Error 0.390	-2.935 Units on a scale Standard Error 0.392
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 Symptoms (N=1704,1688)	-6.555 Units on a scale Standard Error 0.530	-3.268 Units on a scale Standard Error 0.532

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data.

Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

Outcome measures

Outcome measures
Measure	Tiotropium n=1879 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1866 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29	0.176 Litres Standard Error 0.009	0.025 Litres Standard Error 0.009

SECONDARY outcome

Timeframe: Baseline and Day 169

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.

Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

Outcome measures

Outcome measures
Measure	Tiotropium n=1889 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1870 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169	0.179 Litres Standard Error 0.010	0.019 Litres Standard Error 0.010

SECONDARY outcome

Timeframe: Baseline and Day 337

Population: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.

Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

Outcome measures

Outcome measures
Measure	Tiotropium n=1889 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1870 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337	0.168 Litres Standard Error 0.011	-0.001 Litres Standard Error 0.011

SECONDARY outcome

Timeframe: Baseline and end of treatment

Population: Treated set

Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment. SBP - Increase means SBP \>150 mmHg and an increase above baseline of \>25 mmHg. SBP - Decrease means SBP \<100 mmHg and a decrease below baseline of \>10 mmHg. DBP - Increase means DBP \>90 mmHg and an increase above baseline of \>10 mmHg. DBP - Decrease means DBP \<60 mmHg and a decrease below baseline of \>10 mmHg. PR - Increase means PR \>100 bpm and an increase above baseline of \>10 bpm. PR - Decrease means PR \<60 bpm and a decrease below baseline of \>10 bpm.

Outcome measures

Outcome measures
Measure	Tiotropium n=1747 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1749 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Marked Changes From Baseline in Vital Signs at End of Treatment SBP - Increase	29 participants	31 participants
Marked Changes From Baseline in Vital Signs at End of Treatment SBP - Decrease	6 participants	12 participants
Marked Changes From Baseline in Vital Signs at End of Treatment DBP - Increase	40 participants	39 participants
Marked Changes From Baseline in Vital Signs at End of Treatment DBP - Decrease	9 participants	14 participants
Marked Changes From Baseline in Vital Signs at End of Treatment PR - Increase	35 participants	43 participants
Marked Changes From Baseline in Vital Signs at End of Treatment PR - Decrease	26 participants	26 participants

SECONDARY outcome

Timeframe: End of treatment

Population: Treated set

Clinically relevant findings in Physical Examination and ECG at end of treatment

Outcome measures

Outcome measures
Measure	Tiotropium n=1952 Participants Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1965 Participants Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Clinically Relevant Findings in Physical Examination and ECG Phys. Exam - No new/worsened finding	1723 participants	1733 participants
Clinically Relevant Findings in Physical Examination and ECG Phys. Exam - new or worsened finding	22 participants	17 participants
Clinically Relevant Findings in Physical Examination and ECG Phys. Exam - Missing	207 participants	215 participants
Clinically Relevant Findings in Physical Examination and ECG ECG - No new/worsened finding	1674 participants	1677 participants
Clinically Relevant Findings in Physical Examination and ECG ECG - new or worsened finding	37 participants	39 participants
Clinically Relevant Findings in Physical Examination and ECG ECG - Missing	241 participants	249 participants

Adverse Events

Tiotropium

Serious events: 342 serious events

Other events: 866 other events

Deaths: 0 deaths

Placebo

Serious events: 336 serious events

Other events: 926 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Tiotropium n=1952 participants at risk Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Placebo n=1965 participants at risk Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Infections and infestations Nasopharyngitis	8.0% 157/1952 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site	7.7% 151/1965 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site
Infections and infestations Upper respiratory tract infection	5.0% 97/1952 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site	6.3% 123/1965 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	28.7% 561/1952 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site	33.5% 659/1965 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 122/1952 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site	7.3% 144/1965 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site
Respiratory, thoracic and mediastinal disorders Cough	6.3% 123/1952 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site	5.4% 106/1965 • From first drug administration until 30 days after last drug administration. 74 patients were excluded from the treated set due to potential fraudulent data from one investigator site

Additional Information

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

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 of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER