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

NCT ID: NCT00530842

Last Updated: 2013-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Interventions

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Tiotropium plus Salmeterol

Intervention Type DRUG

Fluticasone/Salmeterol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. The patient has a clinical diagnosis of chronic obstructive pulmonary disease (COPD).
3. The patient has relatively stable, moderate to severe airway obstruction.
4. 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):

1. 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
2. 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)
3. 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
4. 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
5. The patient is at least 40 years and less than or equal to 75 years old.
6. 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.
7. 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.
8. The patient is able to inhale the trial medication from the HandiHaler device.
9. The patient is able to inhale the trial medication from the Diskus/Accuhaler device.

Exclusion Criteria

1. a significant disease other than chronic obstructive pulmonary disease (COPD). (review contraindications for exercise testing),
2. a recent history of myocardial infarction within one year.
3. 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.
4. daytime supplemental oxygen.
5. a diagnosis of known active tuberculosis.
6. a history of cancer within the last 5 years.
7. a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
8. thoracotomy with pulmonary resection.
9. an upper respiratory tract infection or an exacerbation of chronic obstructive pulmonary disease (COPD)
10. a known hypersensitivity to anticholinergic drug, ß-adrenergic or corticosteroids, lactose or any other component of the inhalation capsule delivery system.
11. a known symptomatic prostatic hypertrophy or bladder neck obstruction.
12. a known moderate or severe renal insufficiency.
13. a known narrow-angle glaucoma.
14. a known untreated hypokalemia.
15. a known untreated thyrotoxicosis.
16. a history of asthma, allergic rhinitis or atopy, or a total blood eosinophil count larger than 600/mm3.
17. treatment with cromolyn sodium or nedocromil sodium
18. treatment with antihistamines or antileukotrienes.
19. treatment with tiotropium for 1 month before Visit 1.
20. treatment with oral corticosteroid medication.
21. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
22. a history of or active alcohol or drug abuse.
23. an investigational drug within 1 month or 10 half lives
24. a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea.
25. participation in a rehabilitation program for chronic obstructive pulmonary disease (COPD).
26. treatment with monoamine oxidase inhibitors inhibitors or tricyclic antidepressants.
27. participation in another study.
28. more than eight puffs of salbutamol/day during the run-in period
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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205.334.4309 Boehringer Ingelheim Investigational Site

Gänserndorf, , Austria

Site Status

205.334.4308 Boehringer Ingelheim Investigational Site

Hallein, , Austria

Site Status

205.334.4306 Boehringer Ingelheim Investigational Site

Leoben, , Austria

Site Status

205.334.4301 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

205.334.4302 Boehringer Ingelheim Investigational Site

Neumarkt am Wallersee, , Austria

Site Status

205.334.4305 Boehringer Ingelheim Investigational Site

Salzburg, , Austria

Site Status

205.334.1009 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

205.334.1003 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

205.334.1005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

205.334.1008 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Site Status

205.334.1004 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

205.334.1010 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

205.334.1001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

205.334.1006 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

205.334.1007 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

205.334.3303A Boehringer Ingelheim Investigational Site

Beuvry, , France

Site Status

205.334.3303B Boehringer Ingelheim Investigational Site

Beuvry, , France

Site Status

205.334.3305A Boehringer Ingelheim Investigational Site

Créteil, , France

Site Status

205.334.3301A Boehringer Ingelheim Investigational Site

Grenoble, , France

Site Status

205.334.3304A Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, , France

Site Status

205.334.3306A Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

205.334.3306B Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

205.334.3302A Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

205.334.3302B Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

205.334.4908 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

205.334.4909 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

205.334.4902 Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

205.334.4904 Boehringer Ingelheim Investigational Site

Donaustauf, , Germany

Site Status

205.334.4901 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Site Status

205.334.4907 Boehringer Ingelheim Investigational Site

Kiel, , Germany

Site Status

205.334.39007 Boehringer Ingelheim Investigational Site

Catania, , Italy

Site Status

205.334.39002 Boehringer Ingelheim Investigational Site

Gaiato Pavullo (mo), , Italy

Site Status

205.334.39004 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

205.334.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

205.334.39005 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

205.334.39006 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

205.334.7001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.334.7002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

205.334.7003 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

205.334.46003 Boehringer Ingelheim Investigational Site

Jönköping, , Sweden

Site Status

205.334.46002 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

205.334.46001 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

Countries

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Austria Canada France Germany Italy Russia Sweden

References

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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.

Reference Type DERIVED
PMID: 22749044 (View on PubMed)

Related Links

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http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.334_Literature.pdf

Related Info

Other Identifiers

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205.334

Identifier Type: -

Identifier Source: org_study_id