Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.
NCT00563381
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1:
Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 <=70% of predicted normal and FEV1 <=70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC.
For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females:FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres)) - 0.025 x age (years) - 2.60
2. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
3. Male or female patients 40 years of age or older.
4. Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or systemic steroids and/or hospitalisation.
5. Patients must be current or ex-smokers with a smoking history of >= 10 pack-years. (Patients who have never smoked cigarettes must be excluded.)
6. Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).
7. Patients must be able to inhale medication in a competent manner from the HandiHaler and a metered dose inhaler (MDI).
8. Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol.
1. Significant diseases other than COPD. A significant disease is defined as a disease or
condition which, in the opinion of the investigator, may put the patient at risk
because of participation in the study or may influence either the results of the study
or the patients' ability to participate in the study.
2. Patients with a diagnosis of asthma.
3. Patients with a life-threatening pulmonary obstruction, or a history of cystic
fibrosis.
4. Patients with known active tuberculosis.
5. Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction.
Patients with symptomatically-controlled prostatic hyperplasia on medication may be
included and should continue their medication.
6. Patients with known narrow-angle glaucoma.
7. Patients with a history of myocardial infarction within the year prior to Visit 1.
8. Patients with a history of hospital admission for heart failure within the year prior
to Visit 1.
9. Patients with cardiac arrhythmia requiring medical or surgical treatment.
10. Patients with severe cardiovascular disorders.
11. Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics,
lactose or any other component of the medication delivery system.
12. Patients with known moderate or severe renal insufficiency (known creatinine clearance
of <= 50 mL/min).
13. Patients with untreated known hypokalaemia.
14. Patients with untreated known thyrotoxicosis.
15. Patients with brittle/unstable diabetes mellitus.
16. Patients with a history of and/or active significant alcohol or drug abuse. See
exclusion criterion 1.
17. Patients who have taken an investigational drug within 30 days or six half-lives
(whichever is greater) prior to Screening Visit (Visit 1).
18. Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks
on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day
or 20 mg every other day.
19. Pregnant or nursing women or women of childbearing potential not using a medically
approved means of contraception (i.e oral contraceptives, intrauterine devices,
diaphragm or subdermal implants e.g Norplant) for at least three months prior to, and
for the duration of the trial.
20. Previous participation (receipt of randomised treatment) in this study.
21. Patients who are currently participating in another study.
22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior
to the Screening Visit (Visit 1) or during the run-in period should be postponed. In
the case of a respiratory infection or COPD exacerbation during the run-in period, the
latter may be extended up to four weeks.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Birmingham, Alabama
- Jasper, Alabama
- Torrance, California
- Hartford, Connecticut
- Springfield, Illinois
- Muncie, Indiana
- Livonia, Michigan
- Lebanon, New Hampshire
- Charlotte, North Carolina
- Pittsburgh, Pennsylvania
- Spartanburg, South Carolina
- Kingston, Ontario
- Montreal, Quebec
- Montreal, Quebec
- Ste-Foy, Quebec
- Amherstburg, Ontario
- Chatham, Ontario
- Harrow, Ontario
- Leamington, Ontario
- Andrychow,
- Bialystok,
- Bialystok,
- Bialystok,
- Bialystok,
- Bialystok,
- Bielsko-Biala,
- Bielsko-Biala,
- Bielsko-Biala,
- Biskupiec,
- Bochnia,
- Brzesko,
- Brzesko,
- Brzeziny,
- Brzozow,
- Bydgoszcz,
- Bydgoszcz,
- Bydgoszcz,
- Bydgoszcz,
- Bydgoszcz,
- Chelmsko Slaskie,
- Chelm,
- Chelm,
- Chodziez,
- Chojnice,
- Chorzow,
- Chorzow,
- Ciechanow,
- Czarnkow,
- Czestochowa,
- Czestochowa,
- Dabrowa Gornicza,
- Domaradz,
- Dziergowice,
- Gdansk,
- Gdansk,
- Gdansk,
- Gdansk,
- Gdansk,
- Gdansk,
- Gdansk,
- Gdansk,
- Gdynia,
- Gliwice,
- Glucholazy,
- Gora,
- Gorzow Wielkopolski,
- Grodzisk Mazowiecki,
- Grodzisk Mazowiecki,
- Gryfice,
- Jaroslaw,
- Jaslo,
- Jaslo,
- Jaslo,
- Jedrzejow,
- Jelenia Gora,
- Katowice,
- Katowice,
- Katowice,
- Katowice,
- Kcynia,
- Kielce,
- Kielce,
- Kielce,
- Klodzko,
- Kolobrzeg,
- Konin,
- Konskie,
- Konskie,
- Koszalin,
- Koszalin,
- Krakow,
- Krakow,
- Krakow,
- Krakow,
- Krakow,
- Krakow,
- Krakow,
- Krakow,
- Krakow,
- Krasnik,
- Krasnik,
- Krasnik,
- Krosno,
- Kutno,
- Ledziny,
- Legionowo,
- Lisnik Duzy,
- Lodz,
- Lodz,
- Lodz,
- Lodz,
- Lodz,
- Lomza,
- Lomza,
- Lowicz,
- Luban,
- Lubartow,
- Lubin,
- Lubin,
- Lubin,
- Lubliniec,
- Lublin,
- Lublin,
- Lublin,
- Lublin,
- Lubon,
- Ludwikowo,
- Lukow,
- Makow Mazowiecki,
- Malbork,
- Mielec,
- Milicz,
- Myslowice,
- Myszkow,
- Nisko,
- Nowy Dwor Gdanski,
- Nowy Sacz,
- Olawa,
- Olecko,
- Olsztyn,
- Opatow,
- Ostrowiec Swietokrzyski,
- Ostrowiec Swietokrzyski,
- Pabianice,
- Papowo Biskupie,
- Pawonkow,
- Piekary Slaskie,
- Pietrzykowice,
- Pila,
- Piotrkow Trybunalski,
- Plock,
- Pniewy,
- Poniatowa,
- Poznan,
- Poznan,
- Poznan,
- Poznan,
- Poznan,
- Prabuty,
- Proszowice,
- Pruszcz Gdanski,
- Przemysl,
- Rabka Zdroj,
- Radom,
- Radom,
- Ruda Slaska,
- Ruda Slaska,
- Ruda Slaska,
- Ruda Slaska,
- Rumia,
- Rumia,
- Rumia,
- Rybnik,
- Rybnik,
- Rybnik,
- Rzeszow,
- Rzeszow,
- Sanok,
- Sawin,
- Sejny,
- Siewierz,
- Skarzysko Kamienna,
- Skawina,
- Skoczow,
- Skrzyszow,
- Slawno,
- Slubice,
- Slupca,
- Sokolowsko,
- Sopot,
- Sosnowiec,
- Sosnowiec,
- Srem,
- Srem,
- Stalowa Wola,
- Starachowice,
- Starachowice,
- Stargard Szczecinski,
- Sucha Beskidzka,
- Suprasl,
- Suwalki,
- Suwalki,
- Swidnik,
- Swiecie,
- Sycow,
- Szczecinek,
- Szczecin,
- Szczecin,
- Szczecin,
- Szczecin,
- Szczecin,
- Tarnobrzeg,
- Tarnobrzeg,
- Tarnowskie Gory,
- Tarnow,
- Tarnow,
- Torun,
- Torun,
- Torun,
- Trzcianka Lubuska,
- Twardogora,
- Tychy,
- Tychy,
- Uchanie,
- Walcz,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Wejherowo,
- Wieliczna,
- Wielun,
- Witonia,
- Wloc³awek,
- Wodzislaw Slaski,
- Wolomin,
- Wroclaw,
- Wroclaw,
- Wroclaw,
- Wroclaw,
- Wroclaw,
- Wroclaw,
- Wroclaw,
- Zabkowice Slaskie,
- Zabkowice Slaskie,
- Zabrze,
- Zabrze,
- Zabrze,
- Zagoty,
- Zblewo,
- Zgierz,
- Zielona Gora,
- Zielona Gora,
- Zielonka k/Warszawy,
- Zyrardow,
- Birmingham, Alabama
- Birmingham, Alabama
- Jasper, Alabama
- Palo Alto, California
- San Diego, California
- Lexington, Kentucky
- Baltimore, Maryland
- Bloomington, Minnesota
- Rochester, Minnesota
- Omaha, Nebraska
- Albuquerque, New Mexico
- Rochester, New York
- Charlotte, North Carolina
- Cincinnati, Ohio
- Pittsburgh, Pennsylvania
- Kingsport, Tennessee
- Clarksburg, West Virginia
- Gilly,
- Leuven,
- Menen,
- Yvoir,
- Vancouver, British Columbia
- Kingston, Ontario
- Toronto, Ontario
- Ste-Foy, Quebec
- Cvikov,
- Hradec Kralove,
- Karlovy Vary,
- Liberec,
- Neratovice,
- Pardubice,
- Praha 10,
- Praha 3,
- Praha 6,
- Strakonice,
- Tabor,
- Usti nad Labem,
- Berlin,
- Berlin,
- Gelnhausen,
- Rüdersdorf,
- Ulm,
- Athens,
- Athens,
- Thessaloniki,
- Enschede,
- Etten Leur,
- Spijkenisse,
- Zutphen,
- Amadora,
- Coimbra,
- Lisboa,
- Dnipropetrovsk,
- Kharkiv,
- Kharkov,
- Kharkov,
- Kiev,
- Kiev,
- Simferopol,
- Garston, Watford,
- Harrow,
- Warminster,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients. | |||
Official Title ICMJE | Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study). | |||
Brief Summary | This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits. The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations. The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation. The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator. Only COPD exacerbations with onset during randomised treatment will be included in the analysis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Pulmonary Disease, Chronic Obstructive | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | 7376 | |||
Original Enrollment ICMJE | 6800 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 40 Years and older (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 | Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Turkey, Ukraine, United Kingdom | |||
Removed Location Countries | Greece | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00563381 | |||
Other Study ID Numbers ICMJE | 205.389 EUDRACT2007-001840-33 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Boehringer Ingelheim | |||
Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |