Trial Outcomes & Findings for Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg (NCT NCT00350207)

NCT ID: NCT00350207

Last Updated: 2013-12-24

Results Overview

Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 388 participants
• Primary outcome timeframe: baseline and after 16 weeks of treatment
• Results posted on: 2013-12-24

Participant Flow

Participant milestones

Measure	Tiotropium Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol Salmeterol Metered Aerosol, 50mcg twice daily	Placebo Matching Placebo
Overall Study STARTED	128	134	126
Overall Study COMPLETED	120	128	119
Overall Study NOT COMPLETED	8	6	7

Reasons for withdrawal

Measure	Tiotropium Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol Salmeterol Metered Aerosol, 50mcg twice daily	Placebo Matching Placebo
Overall Study Adverse Event	5	2	2
Overall Study Lack of Efficacy	1	0	2
Overall Study Lost to Follow-up	1	0	1
Overall Study Withdrawal by Subject	0	1	1
Overall Study Other	1	3	1

Baseline Characteristics

Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Baseline characteristics by cohort

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=126 Participants Matching Placebo	Total n=388 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 12.6 • n=5 Participants	42.3 years STANDARD_DEVIATION 13.4 • n=7 Participants	44.0 years STANDARD_DEVIATION 11.9 • n=5 Participants	43.3 years STANDARD_DEVIATION 12.6 • n=4 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	83 Participants n=7 Participants	75 Participants n=5 Participants	240 Participants n=4 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	51 Participants n=7 Participants	51 Participants n=5 Participants	148 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and after 16 weeks of treatment

Population: The Full analysis set (FAS) included patients who received at least one dose of randomised study medication and who had at least four patient diary records for at least one efficacy endpoint in any week after the first administration of the randomised treatment and baseline data for the corresponding efficacy endpoint.

Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial	-3.93 L/min Standard Error 4.873	-3.15 L/min Standard Error 4.64	-24.63 L/min Standard Error 4.835

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Mean weekly morning peak expiratory flow at week 4, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Peak Expiratory Flow at Week 4	360.695 L/min Standard Error 4.244	359.762 L/min Standard Error 4.041	335.515 L/min Standard Error 4.211

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Mean weekly morning peak expiratory flow at week 8, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Peak Expiratory Flow at Week 8	355.42 L/min Standard Error 4.646	350.53 L/min Standard Error 4.424	330.193 L/min Standard Error 4.61

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Mean weekly morning peak expiratory flow at week 12, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Peak Expiratory Flow at Week 12	359.05 L/min Standard Error 4.885	351.3 L/min Standard Error 4.652	332.808 L/min Standard Error 4.847

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Mean weekly morning peak expiratory flow at week 16, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Peak Expiratory Flow at Week 16	355.619 L/min Standard Error 4.868	355.799 L/min Standard Error 4.636	334.525 L/min Standard Error 4.831

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Mean weekly evening peak expiratory flow at week 4, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Peak Expiratory Flow at Week 4	374.496 L/min Standard Error 4.249	366.219 L/min Standard Error 4.045	348.344 L/min Standard Error 4.213

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Mean weekly evening peak expiratory flow at week 8, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Peak Expiratory Flow at Week 8	368.758 L/min Standard Error 4.78	359.586 L/min Standard Error 4.551	345.299 L/min Standard Error 4.74

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Mean weekly evening peak expiratory flow at week 12, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Peak Expiratory Flow at Week 12	366.282 L/min Standard Error 4.851	362.01 L/min Standard Error 4.617	344.291 L/min Standard Error 4.81

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Mean weekly evening peak expiratory flow at week 16, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Peak Expiratory Flow at Week 16	363.657 L/min Standard Error 5.242	360.304 L/min Standard Error 4.99	340.099 L/min Standard Error 5.198

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4	2.301 L Standard Error 0.026	2.316 L Standard Error 0.024	2.161 L Standard Error 0.025

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8	2.254 L Standard Error 0.028	2.287 L Standard Error 0.027	2.164 L Standard Error 0.028

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12	2.256 L Standard Error 0.03	2.254 L Standard Error 0.029	2.156 L Standard Error 0.03

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16	2.3 L Standard Error 0.03	2.278 L Standard Error 0.028	2.188 L Standard Error 0.029

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4	2.369 L Standard Error 0.029	2.318 L Standard Error 0.028	2.25 L Standard Error 0.029

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8	2.32 L Standard Error 0.03	2.301 L Standard Error 0.029	2.239 L Standard Error 0.03

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12	2.31 L Standard Error 0.032	2.299 L Standard Error 0.03	2.231 L Standard Error 0.032

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16	2.343 L Standard Error 0.031	2.291 L Standard Error 0.029	2.215 L Standard Error 0.031

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4	1.267 Unit on a scale Standard Error 0.029	1.22 Unit on a scale Standard Error 0.027	1.232 Unit on a scale Standard Error 0.029

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8	1.182 Unit on a scale Standard Error 0.027	1.176 Unit on a scale Standard Error 0.025	1.21 Unit on a scale Standard Error 0.027

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12	1.203 Unit on a scale Standard Error 0.031	1.194 Unit on a scale Standard Error 0.03	1.224 Unit on a scale Standard Error 0.032

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16	1.196 Unit on a scale Standard Error 0.034	1.135 Unit on a scale Standard Error 0.033	1.185 Unit on a scale Standard Error 0.034

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4	1.612 Unit on a scale Standard Error 0.041	1.486 Unit on a scale Standard Error 0.038	1.615 Unit on a scale Standard Error 0.041

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8	1.504 Unit on a scale Standard Error 0.043	1.481 Unit on a scale Standard Error 0.041	1.613 Unit on a scale Standard Error 0.043

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12	1.519 Unit on a scale Standard Error 0.046	1.436 Unit on a scale Standard Error 0.045	1.542 Unit on a scale Standard Error 0.047

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16	1.536 Unit on a scale Standard Error 0.052	1.461 Unit on a scale Standard Error 0.051	1.647 Unit on a scale Standard Error 0.052

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4	1.735 Unit on a scale Standard Error 0.045	1.637 Unit on a scale Standard Error 0.043	1.744 Unit on a scale Standard Error 0.045

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8	1.603 Unit on a scale Standard Error 0.046	1.569 Unit on a scale Standard Error 0.043	1.699 Unit on a scale Standard Error 0.046

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12	1.572 Unit on a scale Standard Error 0.05	1.495 Unit on a scale Standard Error 0.049	1.682 Unit on a scale Standard Error 0.051

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16	1.609 Unit on a scale Standard Error 0.054	1.476 Unit on a scale Standard Error 0.053	1.711 Unit on a scale Standard Error 0.054

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4	1.549 Unit on a scale Standard Error 0.041	1.514 Unit on a scale Standard Error 0.039	1.583 Unit on a scale Standard Error 0.041

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8	1.475 Unit on a scale Standard Error 0.041	1.478 Unit on a scale Standard Error 0.039	1.545 Unit on a scale Standard Error 0.042

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12	1.458 Unit on a scale Standard Error 0.045	1.436 Unit on a scale Standard Error 0.044	1.52 Unit on a scale Standard Error 0.046

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16	1.446 Unit on a scale Standard Error 0.049	1.415 Unit on a scale Standard Error 0.047	1.593 Unit on a scale Standard Error 0.049

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4	1.699 Unit on a scale Standard Error 0.045	1.627 Unit on a scale Standard Error 0.043	1.735 Unit on a scale Standard Error 0.045

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8	1.557 Unit on a scale Standard Error 0.047	1.571 Unit on a scale Standard Error 0.045	1.643 Unit on a scale Standard Error 0.048

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12	1.57 Unit on a scale Standard Error 0.048	1.482 Unit on a scale Standard Error 0.047	1.62 Unit on a scale Standard Error 0.049

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16	1.623 Unit on a scale Standard Error 0.057	1.482 Unit on a scale Standard Error 0.055	1.691 Unit on a scale Standard Error 0.057

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4	1.679 Unit on a scale Standard Error 0.048	1.605 Unit on a scale Standard Error 0.046	1.652 Unit on a scale Standard Error 0.049

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8	1.519 Unit on a scale Standard Error 0.05	1.56 Unit on a scale Standard Error 0.047	1.575 Unit on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12	1.539 Unit on a scale Standard Error 0.051	1.505 Unit on a scale Standard Error 0.05	1.572 Unit on a scale Standard Error 0.052

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16	1.528 Unit on a scale Standard Error 0.057	1.515 Unit on a scale Standard Error 0.056	1.669 Unit on a scale Standard Error 0.057

SECONDARY outcome

Timeframe: After 6 weeks of treatment

Population: FAS

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3	2.471 L Standard Error 0.031	2.401 L Standard Error 0.03	2.299 L Standard Error 0.031

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4	2.467 L Standard Error 0.031	2.442 L Standard Error 0.03	2.266 L Standard Error 0.031

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5	2.439 L Standard Error 0.03	2.457 L Standard Error 0.029	2.29 L Standard Error 0.03

SECONDARY outcome

Timeframe: After 6 weeks of treatment

Population: FAS

Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3	3.531 L Standard Error 0.034	3.441 L Standard Error 0.033	3.367 L Standard Error 0.034

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4	3.509 L Standard Error 0.035	3.495 L Standard Error 0.033	3.307 L Standard Error 0.034

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5	3.488 L Standard Error 0.034	3.474 L Standard Error 0.033	3.353 L Standard Error 0.034

SECONDARY outcome

Timeframe: After 6 weeks of treatment

Population: FAS

Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3	5.050 Unit on a scale Standard Error 0.067	5.259 Unit on a scale Standard Error 0.064	5.097 Unit on a scale Standard Error 0.067

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mini-AQLQ Overall Score at Visit 4	5.233 Unit on a scale Standard Error 0.066	5.399 Unit on a scale Standard Error 0.063	5.078 Unit on a scale Standard Error 0.066

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mini-AQLQ Overall Score at Visit 5	5.305 Unit on a scale Standard Error 0.068	5.454 Unit on a scale Standard Error 0.064	5.214 Unit on a scale Standard Error 0.067

SECONDARY outcome

Timeframe: After 6 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Systolic blood pressure collected in conjunction with spirometry at 6 weeks

Outcome measures

Measure	Tiotropium n=126 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=131 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=122 Participants Matching Placebo
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3	124.68 mmHg Standard Deviation 14.53	123.11 mmHg Standard Deviation 11.5	126.41 mmHg Standard Deviation 14.48

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Systolic blood pressure collected in conjunction with spirometry at 12 weeks

Outcome measures

Measure	Tiotropium n=121 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=129 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=119 Participants Matching Placebo
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4	124.81 mmHg Standard Deviation 13.86	123.92 mmHg Standard Deviation 12.15	125.18 mmHg Standard Deviation 13.45

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Systolic blood pressure collected in conjunction with spirometry at 16 weeks

Outcome measures

Measure	Tiotropium n=122 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=128 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=119 Participants Matching Placebo
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5	124.23 mmHg Standard Deviation 14.59	123.83 mmHg Standard Deviation 12.82	124.47 mmHg Standard Deviation 13.77

SECONDARY outcome

Timeframe: After 6 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Diastolic blood pressure collected in conjunction with spirometry at 6 weeks

Outcome measures

Measure	Tiotropium n=126 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=131 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=122 Participants Matching Placebo
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3	78.62 mmHg Standard Deviation 9.26	77.62 mmHg Standard Deviation 8.74	79.34 mmHg Standard Deviation 8.37

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Diastolic blood pressure collected in conjunction with spirometry at 12 weeks

Outcome measures

Measure	Tiotropium n=121 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=129 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=119 Participants Matching Placebo
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4	77.88 mmHg Standard Deviation 9.93	77.22 mmHg Standard Deviation 9.23	78.29 mmHg Standard Deviation 8.04

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Diastolic blood pressure collected in conjunction with spirometry at 16 weeks

Outcome measures

Measure	Tiotropium n=122 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=128 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=119 Participants Matching Placebo
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5	79.23 mmHg Standard Deviation 9.35	77.61 mmHg Standard Deviation 7.92	78.38 mmHg Standard Deviation 9.38

SECONDARY outcome

Timeframe: After 6 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Pulse rate collected in conjunction with spirometry at 6 weeks

Outcome measures

Measure	Tiotropium n=125 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=131 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=121 Participants Matching Placebo
Pulse Rate in Conjunction With Spirometry at Visit 3	74.7 bpm Standard Deviation 8.8	74.9 bpm Standard Deviation 8.4	74.2 bpm Standard Deviation 9.4

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Pulse rate collected in conjunction with spirometry at 12 weeks

Outcome measures

Measure	Tiotropium n=121 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=129 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=119 Participants Matching Placebo
Pulse Rate in Conjunction With Spirometry at Visit 4	74.8 bpm Standard Deviation 9.9	74.6 bpm Standard Deviation 9.2	74.2 bpm Standard Deviation 8.4

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits

Pulse rate collected in conjunction with spirometry at 16 weeks

Outcome measures

Measure	Tiotropium n=121 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=128 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=119 Participants Matching Placebo
Pulse Rate in Conjunction With Spirometry at Visit 5	74.4 bpm Standard Deviation 9.9	75.3 bpm Standard Deviation 8.3	74.7 bpm Standard Deviation 10.1

SECONDARY outcome

Timeframe: After 4 weeks of treatment

Population: FAS

PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean PEF Variability at Week 4	12.043 ratio expressed in percent Standard Error 0.611	10.547 ratio expressed in percent Standard Error 0.584	12.085 ratio expressed in percent Standard Error 0.606

SECONDARY outcome

Timeframe: After 8 weeks of treatment

Population: FAS

PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean PEF Variability at Week 8	13.377 ratio expressed in percent Standard Error 0.695	11.252 ratio expressed in percent Standard Error 0.664	12.964 ratio expressed in percent Standard Error 0.689

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: FAS

PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean PEF Variability at Week 12	11.735 ratio expressed in percent Standard Error 0.654	11.320 ratio expressed in percent Standard Error 0.625	11.257 ratio expressed in percent Standard Error 0.648

SECONDARY outcome

Timeframe: After 16 weeks of treatment

Population: FAS

PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%

Outcome measures

Measure	Tiotropium n=128 Participants Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 Participants Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=125 Participants Matching Placebo
Mean PEF Variability at Week 16	11.742 ratio expressed in percent Standard Error 0.656	10.793 ratio expressed in percent Standard Error 0.627	12.305 ratio expressed in percent Standard Error 0.650

Adverse Events

Tiotropium

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Salmeterol

Serious events: 7 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tiotropium n=128 participants at risk Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 participants at risk Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=126 participants at risk Matching Placebo
Gastrointestinal disorders Abdominal pain upper	0.00% 0/128 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/134 • From first study drug administration until 30 days after last randomised study drug administration	0.79% 1/126 • From first study drug administration until 30 days after last randomised study drug administration
Gastrointestinal disorders Nausea	0.00% 0/128 • From first study drug administration until 30 days after last randomised study drug administration	0.75% 1/134 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/126 • From first study drug administration until 30 days after last randomised study drug administration
Infections and infestations Gastroenteritis	0.00% 0/128 • From first study drug administration until 30 days after last randomised study drug administration	0.75% 1/134 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/126 • From first study drug administration until 30 days after last randomised study drug administration
Infections and infestations Meningitis	0.78% 1/128 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/134 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/126 • From first study drug administration until 30 days after last randomised study drug administration
Infections and infestations Pilonidal cyst	0.78% 1/128 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/134 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/126 • From first study drug administration until 30 days after last randomised study drug administration
Injury, poisoning and procedural complications Joint injury	0.00% 0/128 • From first study drug administration until 30 days after last randomised study drug administration	0.75% 1/134 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/126 • From first study drug administration until 30 days after last randomised study drug administration
Injury, poisoning and procedural complications Ligament injury	0.00% 0/128 • From first study drug administration until 30 days after last randomised study drug administration	0.75% 1/134 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/126 • From first study drug administration until 30 days after last randomised study drug administration
Nervous system disorders Headache	0.00% 0/128 • From first study drug administration until 30 days after last randomised study drug administration	0.75% 1/134 • From first study drug administration until 30 days after last randomised study drug administration	0.00% 0/126 • From first study drug administration until 30 days after last randomised study drug administration
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/128 • From first study drug administration until 30 days after last randomised study drug administration	3.0% 4/134 • From first study drug administration until 30 days after last randomised study drug administration	0.79% 1/126 • From first study drug administration until 30 days after last randomised study drug administration

Other adverse events

Measure	Tiotropium n=128 participants at risk Tiotropium inhalation solution, 5mcg once daily PM	Salmeterol n=134 participants at risk Salmeterol Metered Aerosol, 50mcg twice daily	Placebo n=126 participants at risk Matching Placebo
Infections and infestations Nasopharyngitis	3.9% 5/128 • From first study drug administration until 30 days after last randomised study drug administration	2.2% 3/134 • From first study drug administration until 30 days after last randomised study drug administration	7.1% 9/126 • From first study drug administration until 30 days after last randomised study drug administration
Respiratory, thoracic and mediastinal disorders Asthma	12.5% 16/128 • From first study drug administration until 30 days after last randomised study drug administration	11.2% 15/134 • From first study drug administration until 30 days after last randomised study drug administration	12.7% 16/126 • From first study drug administration until 30 days after last randomised study drug administration

Additional Information

Boehringer Ingelheim Pharmaceuticals

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

Restriction type: OTHER