Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.

NCT00563381

Last updated date
Study Location
205.389.1020 Boehringer Ingelheim Investigational Site
Feldbach, , , Austria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1:

Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 <=70% of predicted normal and FEV1 <=70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC.

For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females:FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres)) - 0.025 x age (years) - 2.60

2. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.

3. Male or female patients 40 years of age or older.

4. Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or systemic steroids and/or hospitalisation.

5. Patients must be current or ex-smokers with a smoking history of >= 10 pack-years. (Patients who have never smoked cigarettes must be excluded.)

6. Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).

7. Patients must be able to inhale medication in a competent manner from the HandiHaler and a metered dose inhaler (MDI).

8. Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Significant diseases other than COPD. A significant disease is defined as a disease or
condition which, in the opinion of the investigator, may put the patient at risk
because of participation in the study or may influence either the results of the study
or the patients' ability to participate in the study.


2. Patients with a diagnosis of asthma.


3. Patients with a life-threatening pulmonary obstruction, or a history of cystic
fibrosis.


4. Patients with known active tuberculosis.


5. Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction.
Patients with symptomatically-controlled prostatic hyperplasia on medication may be
included and should continue their medication.


6. Patients with known narrow-angle glaucoma.


7. Patients with a history of myocardial infarction within the year prior to Visit 1.


8. Patients with a history of hospital admission for heart failure within the year prior
to Visit 1.


9. Patients with cardiac arrhythmia requiring medical or surgical treatment.


10. Patients with severe cardiovascular disorders.


11. Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics,
lactose or any other component of the medication delivery system.


12. Patients with known moderate or severe renal insufficiency (known creatinine clearance
of <= 50 mL/min).


13. Patients with untreated known hypokalaemia.


14. Patients with untreated known thyrotoxicosis.


15. Patients with brittle/unstable diabetes mellitus.


16. Patients with a history of and/or active significant alcohol or drug abuse. See
exclusion criterion 1.


17. Patients who have taken an investigational drug within 30 days or six half-lives
(whichever is greater) prior to Screening Visit (Visit 1).


18. Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks
on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day
or 20 mg every other day.


19. Pregnant or nursing women or women of childbearing potential not using a medically
approved means of contraception (i.e oral contraceptives, intrauterine devices,
diaphragm or subdermal implants e.g Norplant) for at least three months prior to, and
for the duration of the trial.


20. Previous participation (receipt of randomised treatment) in this study.


21. Patients who are currently participating in another study.


22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior
to the Screening Visit (Visit 1) or during the run-in period should be postponed. In
the case of a respiratory infection or COPD exacerbation during the run-in period, the
latter may be extended up to four weeks.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.
Official Title  ICMJE Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).
Brief Summary

This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits.

The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations.

The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.

The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator.

Only COPD exacerbations with onset during randomised treatment will be included in the analysis.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Tiotropium bromide
    18 mcg/daily
  • Drug: Salmeterol
    100 mcg/daily
  • Drug: Placebo Salmeterol
    Placebo identical to Salmeterol device
  • Drug: Placebo Tiotropium
    Placebo identical to Tiotropium device
Study Arms  ICMJE
  • Active Comparator: Tiotropium + Placebo
    patients inhale Tiotropium 18mcg once daily via HandiHaler and Placebo MDI twice daily
    Interventions:
    • Drug: Tiotropium bromide
    • Drug: Placebo Salmeterol
  • Active Comparator: Salmeterol + Placebo
    patients inhale Salmeterol 50mcg twice daily via MDI and Placebo HandiHaler once daily
    Interventions:
    • Drug: Salmeterol
    • Drug: Placebo Tiotropium
Publications *

*   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: June 14, 2010)
7376
Original Enrollment  ICMJE
 (submitted: November 23, 2007)
6800
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1:

    Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 <=70% of predicted normal and FEV1 <=70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC.

    For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females:FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres)) - 0.025 x age (years) - 2.60

  2. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
  3. Male or female patients 40 years of age or older.
  4. Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or systemic steroids and/or hospitalisation.
  5. Patients must be current or ex-smokers with a smoking history of >= 10 pack-years. (Patients who have never smoked cigarettes must be excluded.)
  6. Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).
  7. Patients must be able to inhale medication in a competent manner from the HandiHaler and a metered dose inhaler (MDI).
  8. Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol.

Exclusion Criteria:

  1. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
  2. Patients with a diagnosis of asthma.
  3. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis.
  4. Patients with known active tuberculosis.
  5. Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically-controlled prostatic hyperplasia on medication may be included and should continue their medication.
  6. Patients with known narrow-angle glaucoma.
  7. Patients with a history of myocardial infarction within the year prior to Visit 1.
  8. Patients with a history of hospital admission for heart failure within the year prior to Visit 1.
  9. Patients with cardiac arrhythmia requiring medical or surgical treatment.
  10. Patients with severe cardiovascular disorders.
  11. Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other component of the medication delivery system.
  12. Patients with known moderate or severe renal insufficiency (known creatinine clearance of <= 50 mL/min).
  13. Patients with untreated known hypokalaemia.
  14. Patients with untreated known thyrotoxicosis.
  15. Patients with brittle/unstable diabetes mellitus.
  16. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion 1.
  17. Patients who have taken an investigational drug within 30 days or six half-lives (whichever is greater) prior to Screening Visit (Visit 1).
  18. Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day.
  19. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g Norplant) for at least three months prior to, and for the duration of the trial.
  20. Previous participation (receipt of randomised treatment) in this study.
  21. Patients who are currently participating in another study.
  22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior to the Screening Visit (Visit 1) or during the run-in period should be postponed. In the case of a respiratory infection or COPD exacerbation during the run-in period, the latter may be extended up to four weeks.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (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,   Belgium,   Bulgaria,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Latvia,   Lithuania,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Slovenia,   Spain,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries Greece
 
Administrative Information
NCT Number  ICMJE NCT00563381
Other Study ID Numbers  ICMJE 205.389
EUDRACT2007-001840-33
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 Pfizer
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date July 2012

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