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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001414-25 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma. The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tiotropium 5mcg/day | Experimental | patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution |
|
| placebo | Experimental | patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium 5mcg/day | Drug | Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. | Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 24 weeks |
| Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. | The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 24 weeks |
| Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period. | Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. |
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Inclusion criteria:
Exclusion criteria:
Note:
As with other anticholinergic drugs, tiotropium should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.
As with all predominantly renally excreted drugs, patients with moderate to severe renal impairment (known creatinine clearance of <= 50 mL/min) treated with tiotropium should be monitored closely.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 205.417.01061 Boehringer Ingelheim Investigational Site | Fountain Valley | California | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36472162 | Derived | Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. | |
| 31319851 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients treated with matching placebo |
| FG001 | Tio R5 | Patients treated with tiotropium inhalation solution 5 microgram qd |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution |
|
| Baseline and 24 weeks |
| Trough FVC Response at the End of the 24-week Treatment Period. | The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 24 weeks |
| FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | Baseline and 24 weeks |
| FVC (AUC0-3h) Response at the End of the 24-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | Baseline and 24 weeks |
| Peak FEV1 0-3h Response at the End of the 48-week Treatment Period. | Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 48 weeks |
| Trough FEV1 Response at the End of the 48-week Treatment Period. | The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 48 weeks |
| AUC0-3h FEV1 Response at the End of the 48-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | Baseline and 48 weeks |
| Peak FVC 0-3h Response at the End of the 48-week Treatment Period. | Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 48 weeks |
| Trough FVC Response at the End of the 48-week Treatment Period. | The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 48 weeks |
| FVC AUC0-3h Response at the End of the 48-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | Baseline and 48 weeks |
| Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit . | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and last 7 days before week 24 visit |
| Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and last 7 days before week 24 visit |
| Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and last 7 days before week 24 visit |
| Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and last 7 days before week 24 visit |
| Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). 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. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and last 7 days before week 24 visit |
| Time to First Severe Asthma Exacerbation During the 48-week Treatment. | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | 48 weeks |
| Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period. | Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation. | 48 weeks |
| Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period. | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | 48 weeks |
| Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period. | Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation. | 48 weeks |
| Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period. | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | 48 weeks |
| Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period. | Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation. | 48 weeks |
| Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period. | 48 weeks |
| Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period. | 48 weeks |
| Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period. | The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | 24 weeks |
| AQLQ(S) Total Score at the End of the 48-week Treatment Period. | The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | 48 weeks |
| Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period. | For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | 24 weeks |
| ACQ Score at the End of the 48-week Treatment Period. | For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | 48 weeks |
| Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit . | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and last 7 days before week 24 visit |
| Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit . | Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and last 7 days before week 24 visit |
| 205.417.01052 Boehringer Ingelheim Investigational Site |
| Fresno |
| California |
| United States |
| 205.417.01051 Boehringer Ingelheim Investigational Site | Stockton | California | United States |
| 205.417.01056 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | United States |
| 205.417.01065 Boehringer Ingelheim Investigational Site | Pensacola | Florida | United States |
| 205.417.01059 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 205.417.01068 Boehringer Ingelheim Investigational Site | Normal | Illinois | United States |
| 205.417.01063 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States |
| 205.417.01064 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States |
| 205.417.01066 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| 205.417.01069 Boehringer Ingelheim Investigational Site | Ocean City | New Jersey | United States |
| 205.417.01062 Boehringer Ingelheim Investigational Site | Albany | New York | United States |
| 205.417.01058 Boehringer Ingelheim Investigational Site | Great Neck | New York | United States |
| 205.417.01055 Boehringer Ingelheim Investigational Site | Rockville Centre | New York | United States |
| 205.417.01067 Boehringer Ingelheim Investigational Site | High Point | North Carolina | United States |
| 205.417.01070 Boehringer Ingelheim Investigational Site | Canton | Ohio | United States |
| 205.417.01053 Boehringer Ingelheim Investigational Site | Upland | Pennsylvania | United States |
| 205.417.01054 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| 205.417.61051 Boehringer Ingelheim Investigational Site | Concord | New South Wales | Australia |
| 205.417.02051 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada |
| 205.417.02053 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada |
| 205.417.02052 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 205.417.45052 Boehringer Ingelheim Investigational Site | Aalborg | Denmark |
| 205.417.45051 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark |
| 205.417.49052 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 205.417.49054 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 205.417.49053 Boehringer Ingelheim Investigational Site | Lübeck | Germany |
| 205.417.49051 Boehringer Ingelheim Investigational Site | Rüdersdorf | Germany |
| 205.417.49055 Boehringer Ingelheim Investigational Site | Weinheim | Germany |
| 205.417.39052 Boehringer Ingelheim Investigational Site | Bussolengo (vr) | Italy |
| 205.417.39054 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 205.417.39051 Boehringer Ingelheim Investigational Site | Pavia | Italy |
| 205.417.39053 Boehringer Ingelheim Investigational Site | Pietra Ligure (sv) | Italy |
| 205.417.81063 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan |
| 205.417.81056 Boehringer Ingelheim Investigational Site | Hiroshima, Hiroshima | Japan |
| 205.417.81051 Boehringer Ingelheim Investigational Site | Itabashi-ku, Tokyo | Japan |
| 205.417.81059 Boehringer Ingelheim Investigational Site | Kagoshima, Kagoshima | Japan |
| 205.417.81053 Boehringer Ingelheim Investigational Site | Kishiwada, Osaka | Japan |
| 205.417.81057 Boehringer Ingelheim Investigational Site | Kitakyusyu, Fukuoka | Japan |
| 205.417.81058 Boehringer Ingelheim Investigational Site | Koga, Fukuoka | Japan |
| 205.417.81055 Boehringer Ingelheim Investigational Site | Kurashiki, Okayama | Japan |
| 205.417.81064 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan |
| 205.417.81062 Boehringer Ingelheim Investigational Site | Morioka, Iwate | Japan |
| 205.417.81052 Boehringer Ingelheim Investigational Site | Osaka-sayama, Osaka | Japan |
| 205.417.81066 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan |
| 205.417.81065 Boehringer Ingelheim Investigational Site | Seto, Aichi | Japan |
| 205.417.81060 Boehringer Ingelheim Investigational Site | Urasoe, Okinawa | Japan |
| 205.417.81061 Boehringer Ingelheim Investigational Site | Urasoe, Okinawa | Japan |
| 205.417.81054 Boehringer Ingelheim Investigational Site | Wakayama, Wakayama | Japan |
| 205.417.31051 Boehringer Ingelheim Investigational Site | Groningen | Netherlands |
| 205.417.31053 Boehringer Ingelheim Investigational Site | Leeuwarden | Netherlands |
| 205.417.31052 Boehringer Ingelheim Investigational Site | Schiedam | Netherlands |
| 205.417.64054 Boehringer Ingelheim Investigational Site | Auckland NZ | New Zealand |
| 205.417.64053 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand |
| 205.417.64052 Boehringer Ingelheim Investigational Site | Newtown Wellington NZ | New Zealand |
| 205.417.64051 Boehringer Ingelheim Investigational Site | Tauranga | New Zealand |
| 205.417.07051 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 205.417.07052 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 205.417.07053 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 205.417.38153 Boehringer Ingelheim Investigational Site | Belgrade | Serbia |
| 205.417.38152 Boehringer Ingelheim Investigational Site | Kamenitz | Serbia |
| 205.417.38151 Boehringer Ingelheim Investigational Site | Niš | Serbia |
| 205.417.27051 Boehringer Ingelheim Investigational Site | Bellville | South Africa |
| 205.417.27052 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 205.417.27053 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 205.417.27054 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 205.417.90052 Boehringer Ingelheim Investigational Site | Ankara | Turkey (Türkiye) |
| 205.417.90053 Boehringer Ingelheim Investigational Site | Ankara | Turkey (Türkiye) |
| 205.417.90051 Boehringer Ingelheim Investigational Site | İzmit | Turkey (Türkiye) |
| 205.417.38053 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 205.417.38051 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 205.417.38052 Boehringer Ingelheim Investigational Site | Vinnytsia | Ukraine |
| 205.417.44051 Boehringer Ingelheim Investigational Site | Chertsey | United Kingdom |
| 205.417.44053 Boehringer Ingelheim Investigational Site | Exeter | United Kingdom |
| 205.417.44052 Boehringer Ingelheim Investigational Site | Windsor | United Kingdom |
| Derived |
| Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6. |
| 29174062 | Derived | Casale TB, Bateman ED, Vandewalker M, Virchow JC, Schmidt H, Engel M, Moroni-Zentgraf P, Kerstjens HAM. Tiotropium Respimat Add-on Is Efficacious in Symptomatic Asthma, Independent of T2 Phenotype. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):923-935.e9. doi: 10.1016/j.jaip.2017.08.037. Epub 2017 Nov 22. |
| 22938706 | Derived | Kerstjens HA, Engel M, Dahl R, Paggiaro P, Beck E, Vandewalker M, Sigmund R, Seibold W, Moroni-Zentgraf P, Bateman ED. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med. 2012 Sep 27;367(13):1198-207. doi: 10.1056/NEJMoa1208606. Epub 2012 Sep 2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients treated with matching placebo |
| BG001 | Tio R5 | Patients treated with tiotropium inhalation solution 5 microgram qd |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. | Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value. | Posted | Mean | Standard Error | Liter | Baseline and 24 weeks |
|
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| Primary | Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. | The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 24 weeks |
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| Primary | Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable. | Posted | Median | Inter-Quartile Range | Days | 48 weeks |
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| Secondary | Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period. | Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 24 weeks |
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| Secondary | Trough FVC Response at the End of the 24-week Treatment Period. | The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 24 weeks |
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| Secondary | FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 24 weeks |
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| Secondary | FVC (AUC0-3h) Response at the End of the 24-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 24 weeks |
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| Secondary | Peak FEV1 0-3h Response at the End of the 48-week Treatment Period. | Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 48 weeks |
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| Secondary | Trough FEV1 Response at the End of the 48-week Treatment Period. | The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 48 weeks |
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| Secondary | AUC0-3h FEV1 Response at the End of the 48-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 48 weeks |
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| Secondary | Peak FVC 0-3h Response at the End of the 48-week Treatment Period. | Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 48 weeks |
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| Secondary | Trough FVC Response at the End of the 48-week Treatment Period. | The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 48 weeks |
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| Secondary | FVC AUC0-3h Response at the End of the 48-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and 48 weeks |
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| Secondary | Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit . | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | L/min | Baseline and last 7 days before week 24 visit |
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| Secondary | Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | L/min | Baseline and last 7 days before week 24 visit |
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| Secondary | Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and last 7 days before week 24 visit |
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| Secondary | Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Liter | Baseline and last 7 days before week 24 visit |
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| Secondary | Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit. | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). 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. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Percent | Baseline and last 7 days before week 24 visit |
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| Secondary | Time to First Severe Asthma Exacerbation During the 48-week Treatment. | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | All patients from FAS. As < 50 percent (81 of 232 patients in the placebo group and 69 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable. | Posted | 48 weeks |
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| Secondary | Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period. | Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation. | All patients from FAS. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period. | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | All patients from FAS. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period. | Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation. | All patients from FAS. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period. | Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days. | All patients from FAS. | Posted | Number | Participants | 48 weeks |
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| Secondary | Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period. | Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation. | All patients from FAS. As < 50 percent (10 of 232 patients in the placebo group and 8 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable. | Posted | 48 weeks |
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| Secondary | Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period. | All patients from FAS. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period. | All patients from FAS. | Posted | Number | Participants | 48 weeks |
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| Secondary | Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period. | The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Scores on a scale | 24 weeks |
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| Secondary | AQLQ(S) Total Score at the End of the 48-week Treatment Period. | The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Scores on a scale | 48 weeks |
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| Secondary | Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period. | For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Score on a scale | 24 weeks |
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| Secondary | ACQ Score at the End of the 48-week Treatment Period. | For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Scores on a scale | 48 weeks |
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| Secondary | Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit . | Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Days | Baseline and last 7 days before week 24 visit |
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| Secondary | Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit . | Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Mean | Standard Error | Puffs | Baseline and last 7 days before week 24 visit |
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| Post-Hoc | The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984) | The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points. The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program. | FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984) | Posted | Number | percentage of participants | 24 weeks, 48 weeks |
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|
48 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients treated with matching placebo | 25 | 234 | 171 | 234 | ||
| EG001 | Tio R5 | Patients treated with tiotropium inhalation solution 5 microgram qd | 19 | 219 | 134 | 219 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| H1N1 influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Bone neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Ocular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Post cholecystectomy syndrome | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Colonic polyp | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Mechanical ileus | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Eye injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Facial paresis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Shock | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Labile hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Peak expiratory flow rate decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided
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