Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
NCT ID: NCT00696020
Last Updated: 2015-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
360 participants
INTERVENTIONAL
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 1744 CL low dose/tiotropium bromide
BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
BI 1744 CL/tiotropium bromide fixed dose combination
BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Respimat® Inhaler
BI1744CL medium dose/tiotropium bromide
BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
BI 1744 CL/tiotropium bromide fixed dose combination
BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Respimat® Inhaler
BI 1744 CL high dose/tiotropium bromide
BI 1744 CL high dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
BI 1744 CL/tiotropium bromide fixed dose combination
BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Respimat® Inhaler
tiotropium bromide
tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
tiotropium bromide
tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Respimat® Inhaler
Interventions
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BI 1744 CL/tiotropium bromide fixed dose combination
BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
tiotropium bromide
tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Respimat® Inhaler
Eligibility Criteria
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Inclusion Criteria
2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 greater or equal 30% of predicted normal and \<80% of predicted normal and a post-bronchodilator FEV1 / FVC \<70% at Visit 1
3. Male or female patients, 40 years of age or older
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years
5. Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).
Exclusion Criteria
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
3. Patients with a history of asthma or a total blood eosinophil count \>= 600/mm3.
4. Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (\>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF\* interval \> 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
5. Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
6. Patients who have undergone thoracotomy with pulmonary resection
7. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
8. Pregnant or nursing women
9. Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
10. Patients who have previously been randomized in this study or are currently participating in another study
11. Patients who are unable to comply with pulmonary medication restrictions prior to randomization
12. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1237.4.0118 Boehringer Ingelheim Investigational Site
Riverside, California, United States
1237.4.0103 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1237.4.0115 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1237.4.0105 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1237.4.0110 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
1237.4.0117 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1237.4.0104 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
1237.4.0120 Boehringer Ingelheim Investigational Site
Edina, Minnesota, United States
1237.4.0112 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
1237.4.0119 Boehringer Ingelheim Investigational Site
Saint Charles, Missouri, United States
1237.4.0114 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
1237.4.0102 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1237.4.0111 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1237.4.0106 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1237.4.0107 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1237.4.0123 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee, United States
1237.4.0122 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1237.4.0109 Boehringer Ingelheim Investigational Site
New Braunfels, Texas, United States
1237.4.0108 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1237.4.0116 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1237.4.0121 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
1237.4.0101 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia, United States
1237.4.0203 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
1237.4.0201 Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada
1237.4.0202 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1237.4.0205 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1237.4.0208 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1237.4.0206 Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec, Canada
1237.4.0204 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec, Canada
1237.4.0207 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
1237.4.4903 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1237.4.4907 Boehringer Ingelheim Investigational Site
Erfurt, , Germany
1237.4.4902 Boehringer Ingelheim Investigational Site
Gauting, , Germany
1237.4.4908 Boehringer Ingelheim Investigational Site
Halle, , Germany
1237.4.4906 Boehringer Ingelheim Investigational Site
Neuruppin, , Germany
1237.4.4904 Boehringer Ingelheim Investigational Site
Rüdersdorf, , Germany
1237.4.4901 Boehringer Ingelheim Investigational Site
Weinheim, , Germany
Countries
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References
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Maltais F, Hamilton A, Voss F, Maleki-Yazdi MR. Dose Determination for a Fixed-Dose Drug Combination: A Phase II Randomized Controlled Trial for Tiotropium/Olodaterol Versus Tiotropium in Patients with COPD. Adv Ther. 2019 Apr;36(4):962-968. doi: 10.1007/s12325-019-00911-y. Epub 2019 Mar 6.
Other Identifiers
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EudraCT No: 2007-005087-26
Identifier Type: -
Identifier Source: secondary_id
1237.4
Identifier Type: -
Identifier Source: org_study_id
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