Status:
COMPLETED
Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung ...
Eligibility Criteria
Inclusion
- All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
- All patients must have a diagnosis of COPD and must meet the following criteria:
- relatively stable\* airway obstruction with a post-bronchodilator FEV1 \< 80% of predicted normal and post-bronchodilator FEV1 \< 70% of post-bronchodilator FVC at Visit 1 (according to GOLD criteria).
- \* The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation. Predicted normal values will be calculated according to ECSC.
- Male or female patients 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of 10 pack-years.
- Patients must be able to perform technically acceptable pulmonary function tests
- Patients must be able to inhale medication in a competent manner.
- Patients must be able to perform all necessary recordings in the diary.
Exclusion
- Significant diseases other than COPD
- Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
- Patients with a recent history of myocardial infarction.
- Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year.
- Hospitalisation for cardiac failure during the past year.
- Malignancy within the last five years excluded basal cell carcinoma.
- Patients with a history of asthma or who have a total blood eosinophil count 600/mm3.
- Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- Known active tuberculosis.
- Patients with a history of alcohol or drug abuse.
- Thoracotomy with pulmonary resection.
- Rehabilitation program within the last six weeks
- Patients who regularly use daytime oxygen therapy
- Patients who have taken an investigational drug within 30 days
- Use of not allowed medications
- Known hypersensitivity to used drugs or other components of the study medication.
- Pregnant or nursing women
- Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. 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.
- Patients who are currently participating in another study.
Key Trial Info
Start Date :
April 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2009
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00662792
Start Date
April 15 2008
End Date
July 22 2009
Last Update
June 28 2022
Active Locations (12)
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1
1184.13.1302 Boehringer Ingelheim Investigational Site
Berlin, Germany
2
1184.13.1309 Boehringer Ingelheim Investigational Site
Berlin, Germany
3
1184.13.1308 Boehringer Ingelheim Investigational Site
Cottbus, Germany
4
1184.13.1311 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany