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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)

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: tiotropium 5mcg/day (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.

Trough FEV1 Response Determined After a Treatment Period of 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).

Secondary outcome:

Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.

Trough FVC Response at the End of the 24-week Treatment Period.

FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.

FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.

Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.

Trough FEV1 Response at the End of the 48-week Treatment Period.

AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.

Peak FVC 0-3h Response at the End of the 48-week Treatment Period.

Trough FVC Response at the End of the 48-week Treatment Period.

FVC AUC0-3h Response at the End of the 48-week Treatment Period.

Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of 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.

Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.

Mean Pre-dose FEV1-p.m.Response (Diary Data) of 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.

Time to First Severe Asthma Exacerbation During the 48-week Treatment.

Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.

Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.

Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.

Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.

Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.

Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.

Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.

Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.

AQLQ(S) Total Score at the End of the 48-week Treatment Period.

Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.

ACQ Score at the End of the 48-week Treatment Period.

Asthma Symptom Free Days Response During the 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 .

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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. 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.

Locations and Contacts

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, Milano, 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, St. Petersburg, Russian Federation

205.417.07052 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

205.417.07053 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

205.417.38153 Boehringer Ingelheim Investigational Site, Belgrade, Serbia

205.417.38151 Boehringer Ingelheim Investigational Site, Nis, Serbia

205.417.38152 Boehringer Ingelheim Investigational Site, Sremska Kamenica, 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

205.417.90053 Boehringer Ingelheim Investigational Site, Ankara, Turkey

205.417.90051 Boehringer Ingelheim Investigational Site, Izmit, Turkey

205.417.38053 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine

205.417.38051 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

205.417.38052 Boehringer Ingelheim Investigational Site, Vinnytsya, 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

205.417.01061 Boehringer Ingelheim Investigational Site, Fountain Valley, California, United States

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, New Jersey, United States

205.417.61051 Boehringer Ingelheim Investigational Site, Concord, New South Wales, Australia

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

205.417.02051 Boehringer Ingelheim Investigational Site, Mississauga, Ontario, Canada

205.417.02053 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada

205.417.01053 Boehringer Ingelheim Investigational Site, Upland, Pennsylvania, United States

205.417.02052 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada

205.417.01054 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States

Additional Information

Starting date: October 2008
Last updated: September 9, 2014

Page last updated: August 23, 2015

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