Tiotropium / Respimat One Year Study in COPD.

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: Respimat; Drug: Tiotropium

• Registration Number: NCT00387088
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-12
• Primary Completion: 2009-01
• Results First Submitted: 2009-11-13
• Results First Submitted QC: 2009-12-18
• Results First Posted: 2010-01-22
• Status Verified: 2013-09
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3991

Inclusion Criteria

1. Male or female
2. At least 40 years old
3. Smoker or ex-smoker
4. Smoking history > 10 pack-years
5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
2. History of asthma or allergic conditions.
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
5. Known active tuberculosis
6. Known hypersensitivity to anticholinergic drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Respimat	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Tiotropium	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337	Baseline and Day 337	Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation	During actual study treatment period (planned Day 1 to Day 337)	Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29	Baseline and Day 29	Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169	Baseline and Day 169	Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Number of COPD Exacerbations Per Patient - Exposure Adjusted	During actual study treatment period (planned Day 1 to Day 337)	Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Number of COPD Exacerbations Per Patient - naïve Estimate	During actual study treatment period (planned Day 1 to Day 337)	Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Number of Patients With at Least One COPD Exacerbation	During actual study treatment period (planned Day 1 to Day 337)	Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Time to First Hospitalisation for COPD Exacerbation	During actual study treatment period (planned Day 1 to Day 337)	Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted	During actual study treatment period (planned Day 1 to Day 337)	Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate	During actual study treatment period (planned Day 1 to Day 337)	Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation	During actual study treatment period (planned Day 1 to Day 337)	Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337	Baseline and Day 337	The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169	Baseline and Day 169	The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337	Baseline and Day 337	The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169	Baseline and Day 169	The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29	Baseline and Day 29	Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169	Baseline and Day 169	Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337	Baseline and Day 337	Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Marked Changes From Baseline in Vital Signs at End of Treatment	Baseline and end of treatment	Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.; SBP - Increase means SBP \>150 mmHg and an increase above baseline of \>25 mmHg. SBP - Decrease means SBP \<100 mmHg and a decrease below baseline of \>10 mmHg.; DBP - Increase means DBP \>90 mmHg and an increase above baseline of \>10 mmHg. DBP - Decrease means DBP \<60 mmHg and a decrease below baseline of \>10 mmHg.; PR - Increase means PR \>100 bpm and an increase above baseline of \>10 bpm. PR - Decrease means PR \<60 bpm and a decrease below baseline of \>10 bpm.
Clinically Relevant Findings in Physical Examination and ECG	End of treatment	Clinically relevant findings in Physical Examination and ECG at end of treatment

Trial Locations

Locations (334)

205.372.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

205.372.01020 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

205.372.01062 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

205.372.01048 Boehringer Ingelheim Investigational Site; 🇺🇸 Berkeley, California, United States

205.372.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Park, California, United States

205.372.01058 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

205.372.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

205.372.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

205.372.01034 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

205.372.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 Rancho Mirage, California, United States

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