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

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Registration Number: NCT00144339

Lead Sponsor: Boehringer Ingelheim

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5993

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years	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	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.

Secondary Outcome Measures

Name	Time	Method
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24	Month 24
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment	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
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years	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
Time to First Exacerbation	From Day 1 to 4 years	Chronic obstructive pulmonary disease (COPD) exacerbation
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12	Month 12
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18	Month 18
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment	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
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years	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	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	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	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	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	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	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	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
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year	Day 1 to 4 years
Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation	Day 1 to 4 years
Number of Exacerbation Days Per Patient Year	Day 1 to 4 years	Number of exacerbation days normalized by treatment exposure
Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)	Day 1 to 4 years
Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization	From Day 1 to 4 years
Number of Exacerbation Leading to Hospitalization	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	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	Month 1	Estimated FEV1 before bronchodilator at Month 1
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1	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	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	Month 6
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12	Month 12
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12	Month 12
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18	Month 18
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18	Month 18
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24	Month 24
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30	Month 30
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30	Month 30
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36	Month 36
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36	Month 36
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42	Month 42
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42	Month 42	Estimated FEV1 after bronchodilator at Month 42
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48	Month 48
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48	Month 48
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1	Month 1
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1	Month 1
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6	Month 6
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6	Month 6
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12	Month 12
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18	Month 18
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24	Month 24
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24	Month 24
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30	Month 30
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30	Month 30
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36	Month 36
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36	Month 36
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42	Month 42
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42	Month 42
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48	Month 48
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48	Month 48
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1	Month 1
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6	Month 6
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30	Month 30
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36	Month 36
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12	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 Post-bronchodilator Slow Vital Capacity (SVC) at Month 1	Month 1
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24	Month 24
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24	Month 24
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6	Month 6
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12	Month 12
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12	Month 12
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18	Month 18
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18	Month 18
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30	Month 30
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36	Month 36
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42	Month 42
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42	Month 42
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48	Month 48
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48	Month 48
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6	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 18	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	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	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	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	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	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)	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)	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)	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)	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

Trial Locations

Locations (490): 205.235.3779 Boehringer Ingelheim Investigational Site
🇺🇸
Anniston, Alabama, United States
205.235.3785 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
205.235.3804 Boehringer Ingelheim Investigational Site
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Jasper, Alabama, United States
205.235.3795 Boehringer Ingelheim Investigational Site
🇺🇸
Mobile, Alabama, United States
205.235.3759 Boehringer Ingelheim Investigational Site
🇺🇸
Phoenix, Arizona, United States
205.235.3770 Boehringer Ingelheim Investigational Site
🇺🇸
Carmichael, California, United States
205.235.3778 Boehringer Ingelheim Investigational Site
🇺🇸
Escondito, California, United States
205.235.3810 Boehringer Ingelheim Investigational Site
🇺🇸
Lakewood, California, United States
205.235.3758 Boehringer Ingelheim Investigational Site
🇺🇸
Long Beach, California, United States
205.235.3812 Boehringer Ingelheim Investigational Site
🇺🇸
Long Beach, California, United States
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205.235.3779 Boehringer Ingelheim Investigational Site
🇺🇸Anniston, Alabama, United States