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

Last updated date
Study Location
205.417.01061 Boehringer Ingelheim Investigational Site
Fountain Valley, California, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
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
  • Drug: tiotropium 5mcg/day
    Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
  • Drug: placebo
    Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Study Arms  ICMJE
  • Experimental: tiotropium 5mcg/day
    patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
    Intervention: Drug: tiotropium 5mcg/day
  • Experimental: placebo
    patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
    Intervention: Drug: placebo
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
 (submitted: August 19, 2010)
453
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
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:

  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.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Chair:Boehringer IngelheimBoehringer Ingelheim
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