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Trial record 87 of 320 for:    FLUTICASONE AND SALMETEROL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00530842
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : March 10, 2010
Last Update Posted : December 24, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 17, 2007
First Posted Date  ICMJE September 18, 2007
Results First Submitted Date  ICMJE December 30, 2009
Results First Posted Date  ICMJE March 10, 2010
Last Update Posted Date December 24, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Post-dose TGV(FRC) (After 8 Weeks) [ Time Frame: 8 weeks ]
    Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks
  • Endurance Time (After 8 Weeks) [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2007)
Two coprimary efficacy endpoints are defined: a) Postdose TGV(FRC) b) Endurance time to the point of symptom limitation during a constant work rate exercise test at 75% Wcap
Change History Complete list of historical versions of study NCT00530842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2013)
  • Post-dose TGV(FRC) (After 4 Weeks) [ Time Frame: 4 weeks ]
    Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks
  • Endurance Time (After 4 Weeks) [ Time Frame: 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)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 8 weeks ]
    Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes [ Time Frame: 4 weeks ]
    Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 8 weeks ]
    Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 4 weeks ]
    Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 8 weeks ]
    Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 4 weeks ]
    Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 8 weeks ]
    Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 4 weeks ]
    Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 8 weeks ]
    Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
  • Static Lung Volumes (Percent) [ Time Frame: 4 weeks ]
    Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
  • Slow Vital Capacity (SVC) [ Time Frame: 8 weeks ]
    Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)
  • Slow Vital Capacity (SVC) [ Time Frame: 4 weeks ]
    Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)
  • Slow Vital Capacity (SVC) [ Time Frame: 8 weeks ]
    Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)
  • Slow Vital Capacity (SVC) [ Time Frame: 4 weeks ]
    Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 8 weeks ]
    Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 4 weeks ]
    Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 8 weeks ]
    Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 4 weeks ]
    Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 8 weeks ]
    Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 4 weeks ]
    Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 8 weeks ]
    Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 4 weeks ]
    Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)
  • Forced Vital Capacity (FVC) [ Time Frame: 8 weeks ]
    Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
  • Forced Vital Capacity (FVC) [ Time Frame: 4 weeks ]
    Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
  • Forced Vital Capacity (FVC) [ Time Frame: 8 weeks ]
    Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
  • Forced Vital Capacity (FVC) [ Time Frame: 4 weeks ]
    Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
  • FEV1 Over FVC (Percent) [ Time Frame: 8 weeks ]
    Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
  • FEV1 Over FVC (Percent) [ Time Frame: 4 weeks ]
    Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
  • FEV1 Over FVC (Percent) [ Time Frame: 8 weeks ]
    Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
  • FEV1 Over FVC (Percent) [ Time Frame: 4 weeks ]
    Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
  • Symptom Intensity During Exercise [ Time Frame: 8 weeks ]
    Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea
  • Symptom Intensity During Exercise [ Time Frame: 4 weeks ]
    Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea
  • Symptom Intensity During Exercise [ Time Frame: 8 weeks ]
    Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort
  • Symptom Intensity During Exercise [ Time Frame: 4 weeks ]
    Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort
  • Dyspnea and Leg Discomfort [ Time Frame: 8 weeks ]
    Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)
  • Dyspnea and Leg Discomfort [ Time Frame: 8 weeks ]
    Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)
  • Locus of Symptom Limitation at Peak Exercise During Exercise [ Time Frame: baseline ]
    Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)
  • Locus of Symptom Limitation at Peak Exercise During Exercise [ Time Frame: 4 weeks ]
    Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)
  • Locus of Symptom Limitation at Peak Exercise During Exercise [ Time Frame: 8 weeks ]
    Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2007)
Static lung volumes FEV1 and FVC; SVC Symptom intensity during exercise dyspnoea and leg discomfort Locus of symptom limitation at peak exercise during exercise. Safety parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD
Official Title  ICMJE Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Tiotropium plus Salmeterol
  • Drug: Fluticasone/Salmeterol
Study Arms  ICMJE Not Provided
Publications * 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.

*   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
 (submitted: February 5, 2009)
344
Original Enrollment  ICMJE
 (submitted: September 17, 2007)
368
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (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,   Canada,   France,   Germany,   Italy,   Russian Federation,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530842
Other Study ID Numbers  ICMJE 205.334
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 Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP