Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00776984
Registration number
NCT00776984
Ethics application status
Date submitted
13/10/2008
Date registered
22/10/2008
Date last updated
10/09/2014
Titles & IDs
Public title
Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study II)
Query!
Scientific title
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
Query!
Secondary ID [1]
0
0
2008-001414-25
Query!
Secondary ID [2]
0
0
205.417
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - tiotropium 5mcg/day
Treatment: Drugs - placebo
Experimental: tiotropium 5mcg/day - patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Experimental: placebo - patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Treatment: Drugs: tiotropium 5mcg/day
Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Treatment: Drugs: placebo
Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and 24 weeks
Query!
Primary outcome [2]
0
0
Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and 24 weeks
Query!
Primary outcome [3]
0
0
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).
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
48 weeks
Query!
Secondary outcome [1]
0
0
Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and 24 weeks
Query!
Secondary outcome [2]
0
0
Trough FVC Response at the End of the 24-week Treatment Period.
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and 24 weeks
Query!
Secondary outcome [3]
0
0
FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline and 24 weeks
Query!
Secondary outcome [4]
0
0
FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline and 24 weeks
Query!
Secondary outcome [5]
0
0
Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline and 48 weeks
Query!
Secondary outcome [6]
0
0
Trough FEV1 Response at the End of the 48-week Treatment Period.
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline and 48 weeks
Query!
Secondary outcome [7]
0
0
AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline and 48 weeks
Query!
Secondary outcome [8]
0
0
Peak FVC 0-3h Response at the End of the 48-week Treatment Period.
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline and 48 weeks
Query!
Secondary outcome [9]
0
0
Trough FVC Response at the End of the 48-week Treatment Period.
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline and 48 weeks
Query!
Secondary outcome [10]
0
0
FVC AUC0-3h Response at the End of the 48-week Treatment Period.
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline and 48 weeks
Query!
Secondary outcome [11]
0
0
Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline and last 7 days before week 24 visit
Query!
Secondary outcome [12]
0
0
Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline and last 7 days before week 24 visit
Query!
Secondary outcome [13]
0
0
Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline and last 7 days before week 24 visit
Query!
Secondary outcome [14]
0
0
Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline and last 7 days before week 24 visit
Query!
Secondary outcome [15]
0
0
Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline and last 7 days before week 24 visit
Query!
Secondary outcome [16]
0
0
Time to First Severe Asthma Exacerbation During the 48-week Treatment.
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
48 weeks
Query!
Secondary outcome [17]
0
0
Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
48 weeks
Query!
Secondary outcome [18]
0
0
Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
48 weeks
Query!
Secondary outcome [19]
0
0
Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
48 weeks
Query!
Secondary outcome [20]
0
0
Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
48 weeks
Query!
Secondary outcome [21]
0
0
Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.
Query!
Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
48 weeks
Query!
Secondary outcome [22]
0
0
Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
48 weeks
Query!
Secondary outcome [23]
0
0
Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
48 weeks
Query!
Secondary outcome [24]
0
0
Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.
Query!
Assessment method [24]
0
0
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.
Query!
Timepoint [24]
0
0
24 weeks
Query!
Secondary outcome [25]
0
0
AQLQ(S) Total Score at the End of the 48-week Treatment Period.
Query!
Assessment method [25]
0
0
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.
Query!
Timepoint [25]
0
0
48 weeks
Query!
Secondary outcome [26]
0
0
Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
24 weeks
Query!
Secondary outcome [27]
0
0
ACQ Score at the End of the 48-week Treatment Period.
Query!
Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
48 weeks
Query!
Secondary outcome [28]
0
0
Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .
Query!
Assessment method [28]
0
0
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.
Query!
Timepoint [28]
0
0
Baseline and last 7 days before week 24 visit
Query!
Secondary outcome [29]
0
0
Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .
Query!
Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
Baseline and last 7 days before week 24 visit
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
1. All patients must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
2. Male or female patients aged at least 18 years but not more than 75 years.
3. All patients must have at least a 5-year history of asthma at the time of enrolment into the trial and the diagnosis of asthma must have been made before the patient´s age of 40.
4. All patients must have a diagnosis of severe persistent asthma and must be symptomatic despite treatment with high, stable doses of inhaled corticosteroids and a long-acting beta adrenergic agent
5. All patients must have a history of one or more asthma exacerbation in the past year.
6. Patients must have evidence of treated, severe, persistent asthma in postbronchodilator pulmonary function tests.
7. Patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years
8. Patients must be able to use the Respimat® inhaler correctly
9. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the electronic diary/peak flow meter.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
1. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient´s ability to participate in the trial.
2. Patients with clinically relevant abnormal screening haematology or blood chemistry.
3. Patients with a recent history (i.e. six months or less) of myocardial infarction, hospitalisation for cardiac failure during the past year, any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year, known active tuberculosis, malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (treated basal cell carcinoma allowed), lung diseases other than asthma (e.g. COPD), significant alcohol or drug abuse within the past two years, patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
4. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
5. Patients using oral corticosteroid medication at stable doses exceeding 5 mg prednisolone or prednisolone equivalent every day or 10 mg prednisolone or prednisolone equivalent every second day.
6. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
7. Pregnant or nursing women or women of childbearing potential not using a highly effective method of birth control. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
8. Patients who have taken an investigational drug within four weeks or six half-lives (whichever is greater) prior to Visit 1.
9. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®), beta-blocker medication, oral beta-adrenergics, other non-approved and according to international guidelines not recommended ´experimental´ drugs for routine asthma therapy (e.g. TNF-alpha blockers, methotrexate, cyclosporin) within four weeks prior to the Screening Visit (Visit 1) or during the screening period.
10. Patients with any asthma exacerbation or respiratory tract infection in the four weeks prior to the trial.
11. Patients who have previously been randomised in this trial or in the respective twin trial (205.416 versus 205.417) or are currently participating in another trial.
12. Patients with a known narrow-angle glaucoma.
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
453
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
205.417.61051 Boehringer Ingelheim Investigational Site - Concord
Query!
Recruitment postcode(s) [1]
0
0
- Concord
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nebraska
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Jersey
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Virginia
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Ontario
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Quebec
Query!
Country [16]
0
0
Denmark
Query!
State/province [16]
0
0
Aalborg
Query!
Country [17]
0
0
Denmark
Query!
State/province [17]
0
0
Aarhus C
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Berlin
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Hamburg
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Lübeck
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Rüdersdorf
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Weinheim
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Bussolengo (vr)
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
Milano
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Pavia
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Pietra Ligure (sv)
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Himeji, Hyogo
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Hiroshima, Hiroshima
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Itabashi-ku, Tokyo
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Kagoshima, Kagoshima
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Kishiwada, Osaka
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Kitakyusyu, Fukuoka
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Koga, Fukuoka
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Kurashiki, Okayama
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Kurume, Fukuoka
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Morioka, Iwate
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Osaka-sayama, Osaka
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Sendai, Miyagi
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Seto, Aichi
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Urasoe, Okinawa
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Wakayama, Wakayama
Query!
Country [42]
0
0
Netherlands
Query!
State/province [42]
0
0
Groningen
Query!
Country [43]
0
0
Netherlands
Query!
State/province [43]
0
0
Leeuwarden
Query!
Country [44]
0
0
Netherlands
Query!
State/province [44]
0
0
Schiedam
Query!
Country [45]
0
0
New Zealand
Query!
State/province [45]
0
0
Auckland NZ
Query!
Country [46]
0
0
New Zealand
Query!
State/province [46]
0
0
Christchurch
Query!
Country [47]
0
0
New Zealand
Query!
State/province [47]
0
0
Newtown Wellington NZ
Query!
Country [48]
0
0
New Zealand
Query!
State/province [48]
0
0
Tauranga
Query!
Country [49]
0
0
Russian Federation
Query!
State/province [49]
0
0
St. Petersburg
Query!
Country [50]
0
0
Serbia
Query!
State/province [50]
0
0
Belgrade
Query!
Country [51]
0
0
Serbia
Query!
State/province [51]
0
0
Nis
Query!
Country [52]
0
0
Serbia
Query!
State/province [52]
0
0
Sremska Kamenica
Query!
Country [53]
0
0
South Africa
Query!
State/province [53]
0
0
Bellville
Query!
Country [54]
0
0
South Africa
Query!
State/province [54]
0
0
Cape Town
Query!
Country [55]
0
0
Turkey
Query!
State/province [55]
0
0
Ankara
Query!
Country [56]
0
0
Turkey
Query!
State/province [56]
0
0
Izmit
Query!
Country [57]
0
0
Ukraine
Query!
State/province [57]
0
0
Kharkov
Query!
Country [58]
0
0
Ukraine
Query!
State/province [58]
0
0
Kiev
Query!
Country [59]
0
0
Ukraine
Query!
State/province [59]
0
0
Vinnytsya
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Chertsey
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Exeter
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Windsor
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Pfizer
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00776984
Query!
Trial related presentations / publications
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. 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00776984
Download to PDF