A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)

NCT00239421 | Completed Phase 4

• 1 other identifier: 205.287
• Study Type: interventional
• Target: 605
• Locations: 8 countries
• Sites: 56

Brief Summary

To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable was forced expiratory volume in one second (FEV1). There were two co-primary endpoints: FEV1 area under the curve for the time period 0 to 12 hours [FEV1 AUC (0-12)] and peak FEV1 measured after 6 weeks of treatment.

Secondary Outcomes (1)

• Secondary endpoints were trough FEV1, trough FVC, peak FVC and FVC AUC (0-12) measured at the same times as FEV1 after six weeks of treatment, individual FEV1 and FVC profiles, rescue medication use, peak expiratory flow, results of safety measurements.

Interventions

Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule) DRUG

Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d. DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (56)

Med. Uni.-Klinik Graz

Graz, 8036, Austria

Location

Boehringer Ingelheim Investigational Site

Vienna, 1120, Austria

Location

Klinikum Kreuzschwestern Wels

Wels, 4600, Austria

Location

Sint-Vincentius Ziekenhuis

Antwerp, 2018, Belgium

Location

CHU Notre Dame des Bruyères

Chênée, 4032, Belgium

Location

Heilig Hartziekenhuis Campus Menen

Menen, 8930, Belgium

Location

Boehringer Ingelheim Investigational Site

Vosselaar, 2350, Belgium

Location

Lungemedicinsk Forskning 2B

Aarhus, DK-8000, Denmark

Location

Bispebjerg Hospital

Copenhagen NV, DK-2400, Denmark

Location

Amtssygehuset i Gentofte

Hellerup, DK-2900, Denmark

Location

Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

Odense Universitetshospital

Odense C, DK-5000, Denmark

Location

Centre Hospitalier Germon et Gauthier

Beuvry, 62660, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Boehringer Ingelheim Investigational Site

Grenoble, 38100, France

Location

Boehringer Ingelheim Investigational Site

Lagord, 17140, France

Location

Clinique de la Louvière

Lille, 59042, France

Location

Boehringer Ingelheim Investigational Site

Berlin, 13597, Germany

Location

MEDARS GmbH

Berlin, 14057, Germany

Location

Klinikum der Ruhr-Universität Bochum

Bochum, 44791, Germany

Location

Klinikum der Universität zu Köln

Cologne, 50931, Germany

Location

ClinGuard GmbH

Dortmund, 44263, Germany

Location

Boehringer Ingelheim Investigational Site

Frankfurt am Main, 60323, Germany

Location

Inamed Research GmbH & Co. KG

Gauting, 82131, Germany

Location

Boehringer Ingelheim Investigational Site

Gelnhausen, 63571, Germany

Location

am Krankenhaus Großhansdorf

Großhansdorf, 22927, Germany

Location

Pneumologisches Forschungsinstitut GmbH

Hamburg, 20535, Germany

Location

Boehringer Ingelheim Investigational Site

Hanover, 30176, Germany

Location

Boehringer Ingelheim Investigational Site

Kiel, 24105, Germany

Location

ClinPharm International GmbH & Co. KG

Leipzig, 04229, Germany

Location

Otto-von-Guericke-Universtität Magdeburg

Magdeburg, 39120, Germany

Location

Boehringer Ingelheim Investigational Site

Minden, 32423, Germany

Location

Boehringer Ingelheim Investigational Site

München, 80634, Germany

Location

Poli Longziekten

Almelo, 7609 PP, Netherlands

Location

lokatie Langendijk

Breda, 4819 EV, Netherlands

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

Polikliniek Longziekten

Heerlen, 6419 PC, Netherlands

Location

Poli Longziekten

Hengelo, 7555 DL, Netherlands

Location

UMC St Radboud ziekenhuis

Nijmegen, 6525 GA, Netherlands

Location

Sint Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Afdeling CardioSearch

Veldhoven, 5504 DB, Netherlands

Location

Tiervlei Trial Centre

Bellville, 7530, South Africa

Location

Boehringer Ingelheim Investigational Site

Bloemfontein, 9301, South Africa

Location

UCT Lung Institute

Cape Town, 7700, South Africa

Location

Boehringer Ingelheim Investigational Site

Cape Town, 8001, South Africa

Location

Boehringer Ingelheim Investigational Site

Durban, 4001, South Africa

Location

St. Augustine Hospital

Durban, 4001, South Africa

Location

QdotPharma

George, 6529, South Africa

Location

Boehringer Ingelheim Investigational Site

Johannesburg, 2193, South Africa

Location

Boehringer Ingelheim Investigational Site

Paarl, 7646, South Africa

Location

Boehringer Ingelheim Investigational Site

Pretoria, 0083, South Africa

Location

Lung- och allergikliniken, Länssjukhuset Ryhov

Jönköping, S-551 85, Sweden

Location

Endokrinologmott/Medicinkliniken

Motala, 591 85, Sweden

Location

Lung och allergikliniken

Stockholm, 141 86, Sweden

Location

Lung och allergikliniken

Stockholm, 171 76, Sweden

Location

Lung- och allergikliniken, Universitetssjukhuset

Umeå, S-901 85, Sweden

Location

Related Publications (1)

• Rabe KF, Timmer W, Sagkriotis A, Viel K. Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest. 2008 Aug;134(2):255-262. doi: 10.1378/chest.07-2138. Epub 2008 Apr 10.

  PMID: 18403672 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Pharma GmbH & Co. KG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 17, 2005
• Study Start: November 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

SE (5); DK (5); ZA (10); FR (5); DE (16); AU (3); BE (4); NL (8)