Status:
COMPLETED
A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients.
Detailed Description
Tiotropium (Spiriva®) is a once-daily inhaled anticholinergic for the treatment of COPD. A six-week, multicentre, randomized, double-blind, parallel group study was conducted to compare the efficacy a...
Eligibility Criteria
Inclusion
- All patients must sign an informed consent prior to participation in the trial, which includes medication washout and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease according to the GOLD criteria and must meet the following spirometric criteria:
- a post-bronchodilator FEV1 \< 80% of predicted normal, a post-bronchodilator FEV1/FVC \< 70% at Visit 1, and a morning FEV1 \<= 65% predicted at Visit 2.
- Male or female patients 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of more than 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 from the HandiHaler® device, the Blue Inhaler device, and from a metered dose inhaler (MDI).
Exclusion
- Patients with significant diseases other than COPD.
- Patients with a recent history (i.e., six months or less) of myocardial infarction.
- Patients who have been hospitalized for heart failure (NYHA class III or IV) within 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.
- Patients with a history of cancer within the last five years.
- Patients with known narrow-angle glaucoma.
- Patients with a history of asthma, allergic rhinitis or atopy 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.
- Patients with known active tuberculosis.
- Patients with significant alcohol or drug abuse within the past two years.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the study.
- 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.
- Patients who are being treated with antihistamines (H1 receptor antagonists) for asthma or excluded allergic conditions.
- Patients who have taken an investigational drug within one month or six half lives prior to Visit 1.
- Patients who have been treated with oral beta-adrenergics within one month prior to Visit 1.
- Patients who have been treated with antileukotrienes or leukotriene receptor antagonists for any disease within one month prior to Visit 1.
- Patients who have been treated with oral steroids within six weeks prior to Visit 1.
- Patients who have been treated with monoamine oxidase inhibitors or tricyclic antidepressants within one month prior to Visit 1.
- Patients who have been treated with cromolyn sodium or nedocromil sodium within one month prior to Visit 1.
- Patients who have been treated with inhaled steroids within two months prior to Visit 1, including combinations of inhaled steroids and long-acting beta-adrenergics.
- Patients with known hypersensitivity to anticholinergic drugs, beta adrenergics, lactose or any other components of the inhalation capsule delivery system or any other components of the aerosol delivery systems.
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months.
- Patients with any respiratory infections in the six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
- Patients who are currently participating in another study.
- Patients requiring more than eight puffs of salbutamol on three or more consecutive days during the run-in period.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT00239421
Start Date
November 1 2003
End Date
September 1 2004
Last Update
November 1 2013
Active Locations (56)
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1
Med. Uni.-Klinik Graz
Graz, Austria, 8036
2
Boehringer Ingelheim Investigational Site
Vienna, Austria, 1120
3
Klinikum Kreuzschwestern Wels
Wels, Austria, 4600
4
Sint-Vincentius Ziekenhuis
Antwerp, Belgium, 2018