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

Boehringer Ingelheim344 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

344

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium plus SalmeterolDRUG

Fluticasone/SalmeterolDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (42)

Outcomes

Primary Outcomes

Post-dose TGV(FRC) (After 8 Weeks)

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

Time frame: 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)

Time frame: 8 weeks

Secondary Outcomes

Post-dose TGV(FRC) (After 4 Weeks)

Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks

Time frame: 4 weeks

Endurance Time (After 4 Weeks)

Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)

Time frame: 4 weeks

Static Lung Volumes

Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes

Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

205.334.4309 Boehringer Ingelheim Investigational Site

Gänserndorf, Austria

205.334.4308 Boehringer Ingelheim Investigational Site

Hallein, Austria

205.334.4306 Boehringer Ingelheim Investigational Site

Leoben, Austria

205.334.4301 Boehringer Ingelheim Investigational Site

Linz, Austria

205.334.4302 Boehringer Ingelheim Investigational Site

Neumarkt am Wallersee, Austria

205.334.4305 Boehringer Ingelheim Investigational Site

Salzburg, Austria

205.334.1009 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

205.334.1003 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

205.334.1005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

205.334.1008 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

...and 32 more locations

Static Lung Volumes

Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes

Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes

Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes

Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes

Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes

Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes

Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes

Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes (Percent)

Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes (Percent)

Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes (Percent)

Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes (Percent)

Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes (Percent)

Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes (Percent)

Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Static Lung Volumes (Percent)

Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)

Time frame: 8 weeks

Static Lung Volumes (Percent)

Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)

Time frame: 4 weeks

Slow Vital Capacity (SVC)

Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)

Time frame: 8 weeks

Slow Vital Capacity (SVC)

Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)

Time frame: 4 weeks

Slow Vital Capacity (SVC)

Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)

Time frame: 8 weeks

Slow Vital Capacity (SVC)

Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)

Time frame: 4 weeks