Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD

NCT00530842 | Completed Phase 4 Results

• 1 other identifier: 205.334
• Study Type: interventional
• Target: 344
• Locations: 7 countries
• Sites: 42

Brief Summary

The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD. The secondary objective includes assessment of safety.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Post-dose TGV(FRC) (After 8 Weeks)

  Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks

  8 weeks

• Endurance Time (After 8 Weeks)

  Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)

  8 weeks

Secondary Outcomes (57)

• Post-dose TGV(FRC) (After 4 Weeks)

  4 weeks

• Endurance Time (After 4 Weeks)

  4 weeks

• Static Lung Volumes

  8 weeks

• Static Lung Volumes

  4 weeks

• Static Lung Volumes

  8 weeks

Interventions

Tiotropium plus Salmeterol DRUG

Fluticasone/Salmeterol DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has signed an Informed Consent Form in accordance with GCP and local legislative requirements prior to participation in the trial, i.e., prior to pre-trial washout of any restricted medications.
• The patient has a clinical diagnosis of chronic obstructive pulmonary disease (COPD).
• The patient has relatively stable, moderate to severe airway obstruction.
• The patient has a pre-bronchodilator forced expiratory volume in the first second (FEV1) less than or equal to 65% of predicted normal determined at Visit 1 using the following predicted equations (R94-1408):
• Males Forced expiratory volume in the first second (FEV1) predicted \[Litres (L)\] = 4.30 x Height \[metres\] minus 0.029 x Age \[years\] minus 2.49
• Females Forced expiratory volume in the first second (FEV1) predicted \[Litres (L)\] = 3.95 x Height \[metres\] minus 0.025 x Age \[years\] minus 2.60 and a Thoracic Gas Volume (Functional residual volume) ((TGV)(FRC)) bigger than 120% predicted normal at visit 1 (or historical data not older than 6 month)
• Males Thoracic Gas Volume (Functional residual volume) ((TGV(FRC)) pred. \[Litres (L)\] = 2.34 x Height \[metres\] + 0.009 x Age \[years\] minus 1.09
• Females Thoracic Gas Volume (Functional residual volume) ((TGV(FRC)) pred. \[Litres (L)\] = 2.24 x Height \[metres\] + 0.001 x Age \[years\] minus 1.00
• The patient is at least 40 years and less than or equal to 75 years old.
• The patient has a cigarette smoking history of at least 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
• The patient is able to perform all specified procedures and able to maintain all necessary records during the study period as required in the protocol.
• The patient is able to inhale the trial medication from the HandiHaler device.
• The patient is able to inhale the trial medication from the Diskus/Accuhaler device.

You may not qualify if:

• a significant disease other than chronic obstructive pulmonary disease (COPD). (review contraindications for exercise testing),
• a recent history of myocardial infarction within one year.
• a recent history of heart failure, pulmonary oedema, or patients with cardiac arrhythmia or any contraindication to exercise described in the CTProtocol within the last 3.
• daytime supplemental oxygen.
• a diagnosis of known active tuberculosis.
• a history of cancer within the last 5 years.
• a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
• thoracotomy with pulmonary resection.
• an upper respiratory tract infection or an exacerbation of chronic obstructive pulmonary disease (COPD)
• a known hypersensitivity to anticholinergic drug, ß-adrenergic or corticosteroids, lactose or any other component of the inhalation capsule delivery system.
• a known symptomatic prostatic hypertrophy or bladder neck obstruction.
• a known moderate or severe renal insufficiency.
• a known narrow-angle glaucoma.
• a known untreated hypokalemia.
• a known untreated thyrotoxicosis.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (42)

205.334.4309 Boehringer Ingelheim Investigational Site

Gänserndorf, Austria

Location

205.334.4308 Boehringer Ingelheim Investigational Site

Hallein, Austria

Location

205.334.4306 Boehringer Ingelheim Investigational Site

Leoben, Austria

Location

205.334.4301 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

205.334.4302 Boehringer Ingelheim Investigational Site

Neumarkt am Wallersee, Austria

Location

205.334.4305 Boehringer Ingelheim Investigational Site

Salzburg, Austria

Location

205.334.1009 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

205.334.1003 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

205.334.1005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

205.334.1008 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Location

205.334.1004 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

205.334.1010 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

205.334.1001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

205.334.1006 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

205.334.1007 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

205.334.3303A Boehringer Ingelheim Investigational Site

Beuvry, France

Location

205.334.3303B Boehringer Ingelheim Investigational Site

Beuvry, France

Location

205.334.3305A Boehringer Ingelheim Investigational Site

Créteil, France

Location

205.334.3301A Boehringer Ingelheim Investigational Site

Grenoble, France

Location

205.334.3304A Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, France

Location

205.334.3306A Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

205.334.3306B Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

205.334.3302A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

205.334.3302B Boehringer Ingelheim Investigational Site

Toulouse, France

Location

205.334.4908 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.334.4909 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.334.4902 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

205.334.4904 Boehringer Ingelheim Investigational Site

Donaustauf, Germany

Location

205.334.4901 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

205.334.4907 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

205.334.39007 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

205.334.39002 Boehringer Ingelheim Investigational Site

Gaiato Pavullo (mo), Italy

Location

205.334.39004 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

205.334.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

205.334.39005 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

205.334.39006 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

205.334.7001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.334.7002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.334.7003 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.334.46003 Boehringer Ingelheim Investigational Site

Jönköping, Sweden

Location

205.334.46002 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

205.334.46001 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

Related Publications (1)

• Magnussen H, Paggiaro P, Schmidt H, Kesten S, Metzdorf N, Maltais F. Effect of combination treatment on lung volumes and exercise endurance time in COPD. Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.

  PMID: 22749044 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2009
• Last Updated: December 24, 2013
• Results First Posted: March 10, 2010

Record last verified: 2013-09

Locations

DE (6); RU (3); FR (9); SE (3); IT (6); AU (6); CA (9)