Trial Outcomes & Findings for Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1 (NCT NCT01663987)
NCT ID: NCT01663987
Last Updated: 2018-10-17
Results Overview
Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.
COMPLETED
PHASE4
79 participants
Baseline and 12 weeks
2018-10-17
Participant Flow
Randomized, placebo-controlled, double blind, parallel group design involving an event-driven treatment period up to the close of the study and a minimum 30-day follow-up period up to the close of the study
Participant milestones
| Measure |
Placebo
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
26
|
34
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Other reason not defined above
|
3
|
0
|
Baseline Characteristics
Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1
Baseline characteristics by cohort
| Measure |
Placebo
n=39 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=40 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Treated Set (TS) including patients who had trough FEV1 data at both baseline and week 12
Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.
Outcome measures
| Measure |
Placebo
n=30 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=30 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug
|
-0.051 Litres
Standard Deviation 0.224
|
0.183 Litres
Standard Deviation 0.273
|
PRIMARY outcome
Timeframe: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 yearsPopulation: Treated set of the pooled twin studies 205.478 and 205.477: This set includes all patients who were randomised and took at least one dose of study drug, 157 patients (79 Tiotropium and 78 placebo) were included in this set.
Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality. Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead. This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=78 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=79 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
47.4 Percentage of perticipants
|
53.2 Percentage of perticipants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Treated Set (TS) including patients who had trough FVC data at both baseline and week 12
Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.
Outcome measures
| Measure |
Placebo
n=30 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=30 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Change From Baseline of Trough FVC at 12 Weeks on Study Drug
|
-0.117 Litres
Standard Deviation 0.371
|
0.274 Litres
Standard Deviation 0.308
|
SECONDARY outcome
Timeframe: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 yearsPopulation: Treated set
Percentage of patients with adverse clinical event during on study, which is defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalisation, or all cause mortality.
Outcome measures
| Measure |
Placebo
n=39 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=40 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Percentage of Patients With Adverse Clinical Event on Study
|
59.0 Percentage of participants
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.
Change from baseline of Trough FEV1 (forced expiratory volume in one second) at 12 weeks on study drug. Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug. This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=59 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=60 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
0.035 Litres
Standard Deviation 0.262
|
0.185 Litres
Standard Deviation 0.384
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.
Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug. This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=59 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=60 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
-0.015 Litres
Standard Deviation 0.396
|
0.278 Litres
Standard Deviation 0.447
|
SECONDARY outcome
Timeframe: from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 yearsPopulation: Treated set of the pooled twin studies 205.478 and 205.477
Percentage of patients with COPD exacerbation on study was analysed for the combined study. A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following: 1) Shortness of breath; 2) Sputum production (volume); 3)Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness. Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment. A required change in treatment included either prescription of antibiotics and/or systemic steroids; and a newly prescribed maintenance respiratory medication (i.e. bronchodilators including theophyllines and PDE4-inhibitors). This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=78 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=79 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
44.9 Percentage of participants
|
40.5 Percentage of participants
|
SECONDARY outcome
Timeframe: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 yearsPopulation: Treated set of the pooled twin studies 205.478 and 205.477
Percentage of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study. All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures. Hospitalizations occurring on the same day as discharge were not considered a separate admission. This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=78 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=79 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
26.9 Percentage of participants
|
26.6 Percentage of participants
|
SECONDARY outcome
Timeframe: from date of hospital discharge prior to randomization up to readmission days >1 and <31 daysPopulation: Treated set of the pooled twin studies 205.478 and 205.477
Percentage of patients with 30-day hospital readmission rates outcome events was analysed. Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1. The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days \>1 and \<31 days using the TS. This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=78 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=79 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
5.1 Percentage of participants
|
5.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 yearsPopulation: Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.
Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS. This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=73 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=54 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
1.3 exacerbations per patient year
|
0.9 exacerbations per patient year
|
SECONDARY outcome
Timeframe: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 yearsPopulation: Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.
Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS. This endpoint was analysed using combined data, as specified in the analysis plan.
Outcome measures
| Measure |
Placebo
n=47 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=38 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
0.8 Hospitalisation per patient year
|
0.6 Hospitalisation per patient year
|
SECONDARY outcome
Timeframe: From first drug administration to the last timepoint with information of EXACT-PRO, up to 2 yearsPopulation: This endpoint was not analysed due to the trials being terminated prematurely due to low patient enrollment and the limited amount of data.
Time to event: Time to recovery based on EXACT-PRO total score. The percentage of observed patients recovered by end of study was reported. Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average. Analysis based on Kaplan Meier estimate.
Outcome measures
| Measure |
Placebo
n=76 Participants
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=76 Participants
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
|
94.0 Percentage of patients recovered
|
88.0 Percentage of patients recovered
|
Adverse Events
Placebo
Tiotropium Bromide (18μg)
Serious adverse events
| Measure |
Placebo
n=39 participants at risk
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=40 participants at risk
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Cardiac disorders
Angina pectoris
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
General disorders
Chest pain
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Incision site infection
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Pneumonia
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Respiratory tract infection viral
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Sepsis
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
28.2%
11/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
30.0%
12/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.6%
1/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
Other adverse events
| Measure |
Placebo
n=39 participants at risk
Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
|
Tiotropium Bromide (18μg)
n=40 participants at risk
Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
3/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
5.0%
2/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Bronchitis
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
7.5%
3/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Candida infection
|
7.7%
3/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Oral candidiasis
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Infections and infestations
Sinusitis
|
7.7%
3/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.3%
4/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
0.00%
0/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Psychiatric disorders
Anxiety
|
7.7%
3/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
5.0%
2/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
43.6%
17/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
37.5%
15/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
3/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
2/39 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
2.5%
1/40 • From first dose of study drug up to 30 days after the last dose of study drug, up to 524 days
|
Additional Information
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Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER