Tiotropium / Respimat One Year Study in COPD.

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00387088
First received: October 11, 2006
Last updated: May 7, 2014
Last verified: September 2013

October 11, 2006
May 7, 2014
September 2006
January 2009   (final data collection date for primary outcome measure)
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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.
1.Bronchodilator efficacy (trough FEV1 response) 2.Time to first COPD exacerbation
Complete list of historical versions of study NCT00387088 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and end of treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
    Clinically relevant findings in Physical Examination and ECG at end of treatment
Number of COPD exacerbations per patient; time to first hospitalisation for COP exacerbation; health-related quality of life
Not Provided
Not Provided
 
Tiotropium / Respimat One Year Study in COPD.
Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Device: Respimat
  • Drug: Tiotropium
  • Tiotropium
    Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
    Intervention: Drug: Tiotropium
  • Placebo
    Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
    Intervention: Device: Respimat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3991
Not Provided
January 2009   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   China,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Norway,   Portugal,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT00387088
205.372, 2006-001009-27
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2013

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