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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00144339




Registration number
NCT00144339
Ethics application status
Date submitted
2/09/2005
Date registered
5/09/2005
Date last updated
20/05/2014

Titles & IDs
Public title
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
Scientific 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).
Secondary ID [1] 0 0
205.235
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Timepoint [1] 0 0
From day 30 to 4 years
Primary outcome [2] 0 0
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Timepoint [2] 0 0
From day 30 to 4 years
Secondary outcome [1] 0 0
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Timepoint [1] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Secondary outcome [2] 0 0
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Timepoint [2] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [3] 0 0
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Timepoint [3] 0 0
From day 30 to 4 years
Secondary outcome [4] 0 0
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years
Timepoint [4] 0 0
From day 30 to 4 years
Secondary outcome [5] 0 0
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Timepoint [5] 0 0
From day 30 to 4 years
Secondary outcome [6] 0 0
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years
Timepoint [6] 0 0
From day 30 to 4 years
Secondary outcome [7] 0 0
Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score
Timepoint [7] 0 0
From month 6 to 4 years
Secondary outcome [8] 0 0
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Timepoint [8] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Secondary outcome [9] 0 0
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Timepoint [9] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [10] 0 0
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Timepoint [10] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [11] 0 0
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment
Timepoint [11] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [12] 0 0
Time to First Exacerbation
Timepoint [12] 0 0
From Day 1 to 4 years
Secondary outcome [13] 0 0
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
Timepoint [13] 0 0
Day 1 to 4 years
Secondary outcome [14] 0 0
Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Timepoint [14] 0 0
Day 1 to 4 years
Secondary outcome [15] 0 0
Number of Exacerbation Days Per Patient Year
Timepoint [15] 0 0
Day 1 to 4 years
Secondary outcome [16] 0 0
Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
Timepoint [16] 0 0
Day 1 to 4 years
Secondary outcome [17] 0 0
Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Timepoint [17] 0 0
From Day 1 to 4 years
Secondary outcome [18] 0 0
Number of Exacerbation Leading to Hospitalization
Timepoint [18] 0 0
From Day 1 to 4 years
Secondary outcome [19] 0 0
Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization
Timepoint [19] 0 0
From Day 1 to 4 years
Secondary outcome [20] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Timepoint [20] 0 0
Month 1
Secondary outcome [21] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1
Timepoint [21] 0 0
Month 1
Secondary outcome [22] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Timepoint [22] 0 0
Month 6
Secondary outcome [23] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Timepoint [23] 0 0
Month 6
Secondary outcome [24] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Timepoint [24] 0 0
Month 12
Secondary outcome [25] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Timepoint [25] 0 0
Month 12
Secondary outcome [26] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Timepoint [26] 0 0
Month 18
Secondary outcome [27] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Timepoint [27] 0 0
Month 18
Secondary outcome [28] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Timepoint [28] 0 0
Month 24
Secondary outcome [29] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Timepoint [29] 0 0
Month 24
Secondary outcome [30] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Timepoint [30] 0 0
Month 30
Secondary outcome [31] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Timepoint [31] 0 0
Month 30
Secondary outcome [32] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Timepoint [32] 0 0
Month 36
Secondary outcome [33] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Timepoint [33] 0 0
Month 36
Secondary outcome [34] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Timepoint [34] 0 0
Month 42
Secondary outcome [35] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Timepoint [35] 0 0
Month 42
Secondary outcome [36] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Timepoint [36] 0 0
Month 48
Secondary outcome [37] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Timepoint [37] 0 0
Month 48
Secondary outcome [38] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
Timepoint [38] 0 0
Month 1
Secondary outcome [39] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
Timepoint [39] 0 0
Month 1
Secondary outcome [40] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
Timepoint [40] 0 0
Month 6
Secondary outcome [41] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
Timepoint [41] 0 0
Month 6
Secondary outcome [42] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
Timepoint [42] 0 0
Month 12
Secondary outcome [43] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
Timepoint [43] 0 0
Month 12
Secondary outcome [44] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
Timepoint [44] 0 0
Month 18
Secondary outcome [45] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
Timepoint [45] 0 0
Month 18
Secondary outcome [46] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
Timepoint [46] 0 0
Month 24
Secondary outcome [47] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
Timepoint [47] 0 0
Month 24
Secondary outcome [48] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
Timepoint [48] 0 0
Month 30
Secondary outcome [49] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
Timepoint [49] 0 0
Month 30
Secondary outcome [50] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
Timepoint [50] 0 0
Month 36
Secondary outcome [51] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
Timepoint [51] 0 0
Month 36
Secondary outcome [52] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
Timepoint [52] 0 0
Month 42
Secondary outcome [53] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
Timepoint [53] 0 0
Month 42
Secondary outcome [54] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
Timepoint [54] 0 0
Month 48
Secondary outcome [55] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
Timepoint [55] 0 0
Month 48
Secondary outcome [56] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
Timepoint [56] 0 0
Month 1
Secondary outcome [57] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
Timepoint [57] 0 0
Month 1
Secondary outcome [58] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
Timepoint [58] 0 0
Month 6
Secondary outcome [59] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
Timepoint [59] 0 0
Month 6
Secondary outcome [60] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
Timepoint [60] 0 0
Month 12
Secondary outcome [61] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
Timepoint [61] 0 0
Month 12
Secondary outcome [62] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
Timepoint [62] 0 0
Month 18
Secondary outcome [63] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18
Timepoint [63] 0 0
Month 18
Secondary outcome [64] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24
Timepoint [64] 0 0
Month 24
Secondary outcome [65] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24
Timepoint [65] 0 0
Month 24
Secondary outcome [66] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30
Timepoint [66] 0 0
Month 30
Secondary outcome [67] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30
Timepoint [67] 0 0
Month 30
Secondary outcome [68] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36
Timepoint [68] 0 0
Month 36
Secondary outcome [69] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36
Timepoint [69] 0 0
Month 36
Secondary outcome [70] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42
Timepoint [70] 0 0
Month 42
Secondary outcome [71] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42
Timepoint [71] 0 0
Month 42
Secondary outcome [72] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48
Timepoint [72] 0 0
Month 48
Secondary outcome [73] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48
Timepoint [73] 0 0
Month 48
Secondary outcome [74] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6
Timepoint [74] 0 0
Month 6
Secondary outcome [75] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12
Timepoint [75] 0 0
Month 12
Secondary outcome [76] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18
Timepoint [76] 0 0
Month 18
Secondary outcome [77] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24
Timepoint [77] 0 0
Month 24
Secondary outcome [78] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30
Timepoint [78] 0 0
Month 30
Secondary outcome [79] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36
Timepoint [79] 0 0
Month 36
Secondary outcome [80] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42
Timepoint [80] 0 0
Month 42
Secondary outcome [81] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48
Timepoint [81] 0 0
Month 48
Secondary outcome [82] 0 0
Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)
Timepoint [82] 0 0
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Secondary outcome [83] 0 0
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)
Timepoint [83] 0 0
Day 1 to day 1470
Secondary outcome [84] 0 0
Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)
Timepoint [84] 0 0
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Secondary outcome [85] 0 0
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Timepoint [85] 0 0
Day 1 to day 1470

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
5993
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
205.235.0205 Boehringer Ingelheim Investigational Site - Bankstown
Recruitment hospital [2] 0 0
205.235.0202 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [3] 0 0
205.235.0209 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [4] 0 0
205.235.0204 Boehringer Ingelheim Investigational Site - Cairns
Recruitment hospital [5] 0 0
205.235.0203 Boehringer Ingelheim Investigational Site - Redcliffe
Recruitment hospital [6] 0 0
205.235.0207 Boehringer Ingelheim Investigational Site - Port Lincoln
Recruitment hospital [7] 0 0
205.235.0206 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
205.235.0201 Boehringer Ingelheim Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- Redcliffe
Recruitment postcode(s) [6] 0 0
- Port Lincoln
Recruitment postcode(s) [7] 0 0
- Box Hill
Recruitment postcode(s) [8] 0 0
- Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Capital Federal
Country [37] 0 0
Argentina
State/province [37] 0 0
Parque Velez Sarlfield
Country [38] 0 0
Argentina
State/province [38] 0 0
Rosario
Country [39] 0 0
Argentina
State/province [39] 0 0
Vicente López
Country [40] 0 0
Austria
State/province [40] 0 0
Graz
Country [41] 0 0
Austria
State/province [41] 0 0
Innsbruck
Country [42] 0 0
Austria
State/province [42] 0 0
Leoben
Country [43] 0 0
Austria
State/province [43] 0 0
Wien
Country [44] 0 0
Belgium
State/province [44] 0 0
Anderlecht
Country [45] 0 0
Belgium
State/province [45] 0 0
Baudour
Country [46] 0 0
Belgium
State/province [46] 0 0
Brugge
Country [47] 0 0
Belgium
State/province [47] 0 0
Brussel
Country [48] 0 0
Belgium
State/province [48] 0 0
Bruxelles
Country [49] 0 0
Belgium
State/province [49] 0 0
Dendermonde
Country [50] 0 0
Belgium
State/province [50] 0 0
Edegem
Country [51] 0 0
Belgium
State/province [51] 0 0
Gent
Country [52] 0 0
Belgium
State/province [52] 0 0
Herentals
Country [53] 0 0
Belgium
State/province [53] 0 0
Ieper
Country [54] 0 0
Belgium
State/province [54] 0 0
Kortrijk
Country [55] 0 0
Belgium
State/province [55] 0 0
Leuven
Country [56] 0 0
Belgium
State/province [56] 0 0
Luxembourg
Country [57] 0 0
Belgium
State/province [57] 0 0
Menen
Country [58] 0 0
Belgium
State/province [58] 0 0
Merksem
Country [59] 0 0
Belgium
State/province [59] 0 0
Middelheim
Country [60] 0 0
Belgium
State/province [60] 0 0
Mons
Country [61] 0 0
Belgium
State/province [61] 0 0
Namur
Country [62] 0 0
Belgium
State/province [62] 0 0
Neerpelt
Country [63] 0 0
Belgium
State/province [63] 0 0
Nobressart (ATTERT)
Country [64] 0 0
Belgium
State/province [64] 0 0
Oostende
Country [65] 0 0
Belgium
State/province [65] 0 0
Tournai
Country [66] 0 0
Belgium
State/province [66] 0 0
Turnhout
Country [67] 0 0
Belgium
State/province [67] 0 0
Yvoir
Country [68] 0 0
Brazil
State/province [68] 0 0
Florianópolis - SC
Country [69] 0 0
Brazil
State/province [69] 0 0
Juiz de Fora - MG
Country [70] 0 0
Brazil
State/province [70] 0 0
Porto Alegre - RS
Country [71] 0 0
Brazil
State/province [71] 0 0
Rio de Janeiro - RJ
Country [72] 0 0
Brazil
State/province [72] 0 0
Salvador - BA
Country [73] 0 0
Brazil
State/province [73] 0 0
Santo André - SP
Country [74] 0 0
Brazil
State/province [74] 0 0
São Paulo - SP
Country [75] 0 0
Czech Republic
State/province [75] 0 0
Benesov
Country [76] 0 0
Czech Republic
State/province [76] 0 0
Beroun
Country [77] 0 0
Czech Republic
State/province [77] 0 0
Brno
Country [78] 0 0
Czech Republic
State/province [78] 0 0
Cesky Tesin
Country [79] 0 0
Czech Republic
State/province [79] 0 0
Hradec Kralove
Country [80] 0 0
Czech Republic
State/province [80] 0 0
Jablonec nad Nisou
Country [81] 0 0
Czech Republic
State/province [81] 0 0
Jaromer
Country [82] 0 0
Czech Republic
State/province [82] 0 0
Kromeriz
Country [83] 0 0
Czech Republic
State/province [83] 0 0
Kyjov
Country [84] 0 0
Czech Republic
State/province [84] 0 0
Lovosice
Country [85] 0 0
Czech Republic
State/province [85] 0 0
Marianske Lazne
Country [86] 0 0
Czech Republic
State/province [86] 0 0
Plzen
Country [87] 0 0
Czech Republic
State/province [87] 0 0
Prague 5
Country [88] 0 0
Czech Republic
State/province [88] 0 0
Praha 4
Country [89] 0 0
Czech Republic
State/province [89] 0 0
Praha 5 - Nove Butovice
Country [90] 0 0
Czech Republic
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Solihull, Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00144339
Trial related presentations / 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.
Public notes

Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00144339