Trial Outcomes & Findings for Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma (NCT NCT01340209)
NCT ID: NCT01340209
Last Updated: 2014-07-04
Results Overview
The primary endpoint is the number of patients with drug-related adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
285 participants
Primary outcome timeframe
after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409
Results posted on
2014-07-04
Participant Flow
Participant milestones
| Measure |
Placebo Respimat
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
114
|
114
|
|
Overall Study
COMPLETED
|
52
|
106
|
106
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
8
|
Reasons for withdrawal
| Measure |
Placebo Respimat
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Other reason not defined above
|
3
|
5
|
4
|
Baseline Characteristics
Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma
Baseline characteristics by cohort
| Measure |
Placebo Respimat
n=57 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 13.0 • n=93 Participants
|
44.7 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
42.6 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
44.5 years
STANDARD_DEVIATION 12.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
176 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
109 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409Population: Treated set: all randomised patients who received at least 1 dose of study medication
The primary endpoint is the number of patients with drug-related adverse events
Outcome measures
| Measure |
Placebo Respimat
n=57 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Number of Patients With Drug-related Adverse Events
|
3 participants
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set: all patients of the treated set for which baseline and at least 1 post-baseline efficacy measurement were available
Trough FEV1 response was defined as change from baseline at week 52
Outcome measures
| Measure |
Placebo Respimat
n=56 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Trough FEV1 Response
|
0.075 Liter
Standard Error 0.039
|
0.087 Liter
Standard Error 0.027
|
0.187 Liter
Standard Error 0.027
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Trough FVC response was defined as change from baseline at week 52
Outcome measures
| Measure |
Placebo Respimat
n=56 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Trough FVC Response
|
0.122 Liter
Standard Error 0.044
|
0.085 Liter
Standard Error 0.030
|
0.204 Liter
Standard Error 0.031
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Trough PEF response was defined as change from baseline at week 52
Outcome measures
| Measure |
Placebo Respimat
n=56 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Trough PEF Response
|
35.078 L/min
Standard Error 10.119
|
35.576 L/min
Standard Error 6.917
|
69.254 L/min
Standard Error 7.004
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Weekly mean PEFam response was defined as change from baseline at week 52
Outcome measures
| Measure |
Placebo Respimat
n=56 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Weekly Mean PEFam Response
|
2.288 L/min
Standard Error 7.554
|
10.934 L/min
Standard Error 5.231
|
8.504 L/min
Standard Error 5.267
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Weekly mean PEFpm response was defined as change from baseline at week 52
Outcome measures
| Measure |
Placebo Respimat
n=56 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Weekly Mean PEFpm Response
|
-10.357 L/min
Standard Error 7.566
|
1.101 L/min
Standard Error 5.239
|
6.041 L/min
Standard Error 5.284
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Weekly mean PEF variability response was defined as change from baseline at week 52. The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline.
Outcome measures
| Measure |
Placebo Respimat
n=56 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Weekly Mean PEF Variability Response
|
-0.367 percentage
Standard Error 0.851
|
-0.968 percentage
Standard Error 0.595
|
0.197 percentage
Standard Error 0.595
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.
Outcome measures
| Measure |
Placebo Respimat
n=50 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=105 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=103 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)
|
-0.25 Puffs
Standard Deviation 0.77
|
-0.29 Puffs
Standard Deviation 1.01
|
-0.22 Puffs
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline. 5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.
Outcome measures
| Measure |
Placebo Respimat
n=50 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=103 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=103 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Weekly Mean Score of Asthma Symptoms in the Morning (Response)
|
-0.22 Scores on a scale
Standard Deviation 0.43
|
-0.14 Scores on a scale
Standard Deviation 0.49
|
-0.21 Scores on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: baseline and week 52Population: Full analysis set
Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline. 5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.
Outcome measures
| Measure |
Placebo Respimat
n=50 Participants
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=105 Participants
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=103 Participants
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Weekly Mean Score of Asthma Symptoms During the Day (Response)
|
-0.24 Scores on a scale
Standard Deviation 0.35
|
-0.15 Scores on a scale
Standard Deviation 0.48
|
-0.17 Scores on a scale
Standard Deviation 0.48
|
Adverse Events
Placebo Respimat
Serious events: 9 serious events
Other events: 50 other events
Deaths: 0 deaths
Tiotropium Respimat (2.5 µg)
Serious events: 4 serious events
Other events: 97 other events
Deaths: 0 deaths
Tiotropium Respimat (5 μg)
Serious events: 4 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Respimat
n=57 participants at risk
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 participants at risk
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 participants at risk
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Gastrointestinal disorders
Mesenteric haemorrhage
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
General disorders
Cyst
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Diverticulitis
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Influenza
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Pneumonia bacterial
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Nervous system disorders
Loss of consciousness
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Vascular disorders
Aortic dissection
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
Other adverse events
| Measure |
Placebo Respimat
n=57 participants at risk
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
|
Tiotropium Respimat (2.5 µg)
n=114 participants at risk
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
|
Tiotropium Respimat (5 μg)
n=114 participants at risk
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.0%
4/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
2.6%
3/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
1.8%
2/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.0%
4/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
6.1%
7/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
6.1%
7/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Gastrointestinal disorders
Constipation
|
5.3%
3/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.00%
0/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Gastrointestinal disorders
Gastritis
|
7.0%
4/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
2.6%
3/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
5.3%
6/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
0.88%
1/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
5.3%
6/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Bronchitis
|
7.0%
4/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
13.2%
15/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
9.6%
11/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Gastroenteritis
|
5.3%
3/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
3.5%
4/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
10.5%
12/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Influenza
|
3.5%
2/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
5.3%
6/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
4.4%
5/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Nasopharyngitis
|
42.1%
24/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
44.7%
51/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
48.2%
55/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Pharyngitis
|
3.5%
2/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
13.2%
15/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
7.9%
9/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
2/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
7.0%
8/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
4.4%
5/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
3/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
1.8%
2/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
2.6%
3/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Investigations
Peak expiratory flow rate decreased
|
21.1%
12/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
7.9%
9/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
15.8%
18/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
3/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
3.5%
4/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
3.5%
4/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Nervous system disorders
Headache
|
1.8%
1/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
6.1%
7/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
3.5%
4/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
36.8%
21/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
29.8%
34/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
28.1%
32/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/57 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
1.8%
2/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
6.1%
7/114 • after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
|
Additional Information
Boehringer Ingelheim Call Center
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