Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

• ClinicalTrials.gov Identifier: NCT00144339
• Recruitment Status: Completed
• First Posted: September 5, 2005
• Results First Posted: August 17, 2009
• Last Update Posted: May 20, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by: Boehringer Ingelheim

Tracking Information

• First Submitted Date: September 2, 2005
• First Posted Date: September 5, 2005
• Results First Submitted Date: February 21, 2009
• Results First Posted Date: August 17, 2009
• Last Update Posted Date: May 20, 2014
• Study Start Date: December 2002
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 3, 2009)

• Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
• Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

• Original Primary Outcome Measures (submitted: September 2, 2005): The co-primary endpoints are:yearly rate of decline in pre and post bronchodilator FEV1 from day 30 (steady state) until completion of double-blind treatment.

Current Secondary Outcome Measures (submitted: September 12, 2013)

• Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
  Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
• Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
• Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
• Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
• Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
• Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]
  Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
• Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: From month 6 to 4 years ]
  SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).
• Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
  Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
• Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
• Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
• Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
• Time to First Exacerbation [ Time Frame: From Day 1 to 4 years ]
  Chronic obstructive pulmonary disease (COPD) exacerbation
• Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year [ Time Frame: Day 1 to 4 years ]
• Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: Day 1 to 4 years ]
• Number of Exacerbation Days Per Patient Year [ Time Frame: Day 1 to 4 years ]
  Number of exacerbation days normalized by treatment exposure
• Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients) [ Time Frame: Day 1 to 4 years ]
• Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]
• Number of Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]
  Estimated number of exacerbations leading to hospitalizations per patient year
• Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]
  Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ]
  Estimated FEV1 before bronchodilator at Month 1
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 [ Time Frame: Month 1 ]
  Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ]
  Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 [ Time Frame: Month 6 ]
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ]
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 [ Time Frame: Month 12 ]
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ]
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 [ Time Frame: Month 18 ]
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ]
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 [ Time Frame: Month 24 ]
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ]
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 [ Time Frame: Month 30 ]
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ]
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 [ Time Frame: Month 36 ]
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ]
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 [ Time Frame: Month 42 ]
  Estimated FEV1 after bronchodilator at Month 42
• Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ]
• Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 [ Time Frame: Month 48 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1 [ Time Frame: Month 1 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6 [ Time Frame: Month 6 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12 [ Time Frame: Month 12 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18 [ Time Frame: Month 18 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24 [ Time Frame: Month 24 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 [ Time Frame: Month 30 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36 [ Time Frame: Month 36 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42 [ Time Frame: Month 42 ]
• Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ]
• Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48 [ Time Frame: Month 48 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1 [ Time Frame: Month 1 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6 [ Time Frame: Month 6 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12 [ Time Frame: Month 12 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18 [ Time Frame: Month 18 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24 [ Time Frame: Month 24 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30 [ Time Frame: Month 30 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36 [ Time Frame: Month 36 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36 [ Time Frame: Month 36 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42 [ Time Frame: Month 42 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42 [ Time Frame: Month 42 ]
• Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48 [ Time Frame: Month 48 ]
• Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48 [ Time Frame: Month 48 ]
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6 [ Time Frame: Month 6 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12 [ Time Frame: Month 12 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18 [ Time Frame: Month 18 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24 [ Time Frame: Month 24 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30 [ Time Frame: Month 30 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36 [ Time Frame: Month 36 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42 [ Time Frame: Month 42 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48 [ Time Frame: Month 48 ]
  • SGRQ total score summarizes the impact of COPD on overall patient's health status.
  • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
  • The scale is continuous.
  • Rate of decline shows the yearly change of SGRQ total score.
• Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
  On-treatment defined as day 1 to completion of double blinded treatment plus 30 days
• Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days) [ Time Frame: Day 1 to day 1470 ]
  All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.
• Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
  The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days
• Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days) [ Time Frame: Day 1 to day 1470 ]
  The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used

• Original Secondary Outcome Measures (submitted: September 2, 2005): Rate of decline in pre & post bronchodilator FEV1, FVC & SVC from day 1 until 30 days post treatment, rate of decline in pre & post bronchodilator FVC & SVC day 30 until completion of treatment, exacerbations/hospitalizations, SGRQ total score, mortality

Current Other Pre-specified Outcome Measures (submitted: February 21, 2011)

• Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Angina) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.
• Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
• Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).
• Brief Summary: The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Parallel Assignment; Primary Purpose: Treatment
• Condition: Pulmonary Disease, Chronic Obstructive

Intervention

• Drug: tiotropium
• Drug: placebo

• Study Arms: Not Provided

Publications *

• Rabe KF, Halpin DMG, Han MK, Miravitlles M, Singh D, Gronke L, Voss F, Martinez FJ. Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial. Respir Res. 2020 Jul 9;21(1):177. doi: 10.1186/s12931-020-01431-y.
• Tashkin DP, Miravitlles M, Celli BR, Metzdorf N, Mueller A, Halpin DMG, Anzueto A. Concomitant inhaled corticosteroid use and the risk of pneumonia in COPD: a matched-subgroup post hoc analysis of the UPLIFT(R) trial. Respir Res. 2018 Oct 5;19(1):196. doi: 10.1186/s12931-018-0874-0.
• Celli BR, Decramer M, Liu D, Metzdorf N, Asijee GM, Tashkin DP. Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT(R) trial. Respir Res. 2016 May 4;17(1):48. doi: 10.1186/s12931-016-0361-4.
• Goossens LM, Leimer I, Metzdorf N, Becker K, Rutten-van Molken MP. Does the 2013 GOLD classification improve the ability to predict lung function decline, exacerbations and mortality: a post-hoc analysis of the 4-year UPLIFT trial. BMC Pulm Med. 2014 Oct 18;14:163. doi: 10.1186/1471-2466-14-163.
• Tashkin DP, Li N, Kleerup EC, Halpin D, Celli B, Decramer M, Elashoff R. Acute bronchodilator responses decline progressively over 4 years in patients with moderate to very severe COPD. Respir Res. 2014 Aug 31;15(1):102. doi: 10.1186/s12931-014-0102-5.
• Janssens W, Liu Y, Liu D, Kesten S, Tashkin DP, Celli BR, Decramer M. Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT(R)). Respir Med. 2013 Sep;107(9):1409-16. doi: 10.1016/j.rmed.2013.04.015. Epub 2013 May 25.
• Tashkin DP, Celli BR, Decramer M, Lystig T, Liu D, Kesten S. Efficacy of tiotropium in COPD patients with FEV1 >/= 60% participating in the UPLIFT(R) trial. COPD. 2012 Jun;9(3):289-96. doi: 10.3109/15412555.2012.656211. Epub 2012 Mar 20.
• Kesten S, Celli B, Decramer M, Liu D, Tashkin D. Adverse health consequences in COPD patients with rapid decline in FEV1--evidence from the UPLIFT trial. Respir Res. 2011 Sep 28;12(1):129. doi: 10.1186/1465-9921-12-129.
• Tashkin D, Celli B, Kesten S, Lystig T, Decramer M. Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial. Respir Med. 2010 Oct;104(10):1495-504. doi: 10.1016/j.rmed.2010.03.033. Epub 2010 Apr 24.
• Troosters T, Celli B, Lystig T, Kesten S, Mehra S, Tashkin DP, Decramer M; Uplift Investigators. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur Respir J. 2010 Jul;36(1):65-73. doi: 10.1183/09031936.00127809. Epub 2010 Feb 25.
• Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP; UPLIFT investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1171-8. doi: 10.1016/S0140-6736(09)61298-8. Epub 2009 Aug 27.
• Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 11, 2008): 5993
• Original Enrollment (submitted: September 2, 2005): 6000
• Study Completion Date: Not Provided
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Written informed consent.
• Male or female patients 40 years of age or older.
• Smoking history of at least 10 pack years.
• Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

• Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
• Myocardial infarction in past 6 months.
• Unstable or life threatening arrhythmia in past year.
• Hospitalization for NYHA heart failure class III or IV in past year.
• Active tuberculosis.
• Asthma.
• Pulmonary resection.
• Malignancy treated with radiation or chemotherapy in past 5 years.
• Respiratory infection in 4 weeks prior to screening.
• Known hypersensitivity to anticholinergic drugs or components.
• Known moderate to severe renal impairment.
• Known narrow angle glaucoma.
• Significant symptomatic BPH or bladder neck obstruction.
• Need for oxygen therapy >12 hr/day.
• Use of oral corticosteroids at unstable doses or >10 mg/day.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT00144339
• Other Study ID Numbers: 205.235
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
• Original Responsible Party: Not Provided
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: April 2014