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)
NCT00776984
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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.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | 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) | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Asthma | |||
Intervention ICMJE |
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Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 453 | |||
Original Estimated Enrollment ICMJE | 316 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Canada, Denmark, Germany, Italy, Japan, Netherlands, New Zealand, Russian Federation, Serbia, South Africa, Turkey, Ukraine, United Kingdom, United States | |||
Removed Location Countries | Former Yugoslavia | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00776984 | |||
Other Study ID Numbers ICMJE | 205.417 2008-001414-25 ( EudraCT Number: EudraCT ) | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Boehringer Ingelheim | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Boehringer Ingelheim | |||
Verification Date | September 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |