Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index (BDI)/Transition Dyspnoea Index (TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations
Interventions
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene (PE) Capsule
DRUGSalmeterol
Salmeterol Inhalation Powder, hard PE capsule
DRUGPlacebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
DRUGTiotropium
Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main: * Diagnosis of chronic obstructive pulmonary disease (COPD) * Post-bronchodilator forced expiratory volume in one second (FEV1) \<80% predicted and FEV1/forced vital capacity (FVC) \<70% predicted
Exclusion criteria
Main: * Significant other diseases then COPD * Recent myocardial infarction (MI) * Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year * Hospitalisation for cardiac failure during the past year * History of asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period | At baseline and week 12 | Change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the end of the 12-week treatment period is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer. Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment. Trough FEV1 response is defined as the change from baseline: Trough FEV1 response = Trough FEV1 - FEV1 (Baseline) |
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period | At baseline and week 24 | Change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the end of the 24-week treatment period is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 min time point just prior to inhalation of the morning dose of randomised treatment. |
| Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response at the End of the 12-week Treatment Period | At baseline and at week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8 hours (AUC0-8h) response at the end of the 12-week treatment period is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit. Response = FEV1 AUC0-8h at week 12 - trough FEV1 at baseline. |
| Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response at the End of the 24-week Treatment Period | At baseline and at week 24: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8h (AUC0-8h) response at the end of the 24-week treatment period is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit. Response = FEV1 AUC0-8h at week 24 - trough FEV1 at baseline. |
| Mahler Transition Dyspnoea Index (TDI) Focal Score at the End of the 12-week Treatment Period | At the end of week 12 | The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement). The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement. |
| Mahler Transition Dyspnoea Index (TDI) Focal Score at the End of the 24-week Treatment Period | At the end of week 24 | The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement). The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement. |
| St George Respiratory Questionnaire (SGRQ) Total Score at the End of the 24-week Treatment Period (Based Upon Pooled Data From 48-week Sister Studies 1184.14 and 1184.15) | At the end of week 24 | The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. The evaluation SGRQ was planned to be based upon pooled data from 48-week sister studies 1184.14 and 1184.15. |
| Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Within 48 Weeks | Up to 12 weeks | Time from start of treatment to first moderate to severe chronic obstructive pulmonary disease (COPD) exacerbation within 48 weeks is presented. |
| Number of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Within 48 Weeks | Up to 12 weeks. | Number of patients with moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations within 48 weeks is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response After 4, 36 and 48 Weeks Treatment Period | At baseline and at week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8h (AUC0-8h) response after 4, 36 and 48 weeks treatment period is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit. Response = FEV1 AUC0-8h at week 4, 36 or 48 - trough FEV1 at baseline. |
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) After 4, 36 and 48 Weeks Treatment Period | At baseline and week 4. | Change from baseline in trough Forced Expiratory Volume in one second (FEV1) after 4, 36 and 48 weeks treatment period is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer. Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment. Trough FEV1 response is defined as the change from baseline: Trough FEV1 response = Trough FEV1 - FEV1 (Baseline) |
| Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) at Week 4, 12, 18, 24, 36 and 48 | At baseline and at week 4 and 12: within 3h after inhalation of the morning dose of randomised treatment. | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Peak FEV1 is defined as the highest FEV1 reading observed within 3 hours after inhalation of the morning dose of randomised treatment. Peak FEV1 response is defined as the change from baseline: Peak FEV1 response = Peak FEV1 - FEV1 (Baseline) |
| The Forced Vital Capacity (FVC) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response After 4, 12, 24, 36 and 48 Weeks Treatment Period | At baseline and at week 4 and 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC AUC0-8h is defined as the area under the FVC curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FVC was assigned to zero time. Trough FVC at baseline is defined as the pre-dose FVC measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit. Response = FVC AUC0-8h at week 4, 12, 24, 36 or 48 - trough FVC at baseline. |
| Change From Baseline in Trough Forced Vital Capacity (FVC) After 4, 12, 24, 36 and 48 Weeks Treatment Period | At baseline and week 4 and 12. | Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC is defined as the pre-dose FVC measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment. Trough FVC response is defined as the change from baseline: Trough FVC response = Trough FVC - FVC (Baseline) |
| Change From Baseline in Peak Forced Vital Capacity (FVC) at Week 4, 12, 18, 24, 36 and 48 | At baseline and at week 4 and 12: within 3 hours after inhalation of the morning dose of randomised treatment. | Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC is defined as the highest FVC reading observed within 3 hours after inhalation of the morning dose of randomised treatment. Peak FVC response is defined as the change from baseline: Peak FVC response = Peak FVC - FVC (Baseline) |
| Forced Expiratory Volume in One Second (FEV1) at Clinic Visits at the Individual Times on Week 4 | At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Expiratory Volume in one second (FEV1) at clinic visits at the individual times on week 4 is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer. |
| Forced Expiratory Volume in One Second (FEV1) at Clinic Visits at the Individual Times on Week 12 | At week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Expiratory Volume in one second (FEV1) at clinic visits at the individual times on week 12 is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer. |
| Forced Vital Capacity (FVC) at Clinic Visits at the Individual Times on Week 4 | At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Vital Capacity (FVC) at clinic visits at the individual times on week 4 is presented. Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Forced Vital Capacity (FVC) at Clinic Visits at the Individual Times on Week 12 | At week 12, at 10 min prior and 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Forced Vital Capacity (FVC) at clinic visits at the individual times on week 12 is presented. Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Peak Expiratory Flow (PEF) Rate at Clinic Visits at the Individual Times on Week 4 | At week 4, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Peak expiratory flow (PEF) rate at clinic visits at the individual times on week 4 is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. PEF measurements was performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation were obtained within ± 5 minutes of the specified time-points. Measurements scheduled at 2-8 hours after inhalation were obtained within ± 10 minutes of the specified time-points. PEF is defined as a person's maximum speed of expiration after a full inspiration. |
| Peak Expiratory Flow (PEF) Rate at Clinic Visits at the Individual Times on Week 12 | At week 12, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. | Peak expiratory flow (PEF) rate at clinic visits at the individual times on week 12 is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. PEF measurements will be performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation will be obtained within ± 5 minutes of the specified time-points.Measurements scheduled at 2-8 hours after inhalation will be obtained within ± 10 minutes of the specified time-points. |
| Weekly Mean Morning Pre-dose Peak Expiratory Flows (PEFs) | At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication. | Weekly mean morning pre-dose peak expiratory flows (PEFs) is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. The pulmonary function test was obtained by spirometry. The best of three efforts was defined as the highest PEF. Patients did not take their morning study medications prior to each morning PEF measurement. |
| Weekly Mean Evening Pre-dose Peak Expiratory Flows (PEFs) | At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication. | Weekly mean evening pre-dose peak expiratory flows (PEFs) is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. The pulmonary function test was obtained by spirometry. The best of three efforts was defined as the highest PEF. Patients did not take their evening study medications prior to each evening PEF measurement. |
| Peak Expiratory Flow (PEF) Determined by Spirometry at Week 4, 12, 18, 24, 36 and 48 | At week 4 and 12: 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. | Peak expiratory flow (PEF) are determined by spirometry at clinic visits (week 4, 12, 18, 24, 36 and 48) is presented. Spirometry will begin between 07:00 and 10:00 a.m. PEF measurements will be performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation will be obtained within ± 5 minutes of the specified time-points.Measurements scheduled at 2-8 hours after inhalation will be obtained within ± 10 minutes of the specified time-points. |
| Weekly Mean Morning Pre-dose Forced Expiratory Volume in One Second (FEV1) | At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication. | Weekly mean morning pre-dose Forced expiratory volume in one second (FEV1) is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements are performed individually at home and reported by the patient. It is measured by a spirometer. The best of three efforts was defined as the highest FEV1. Patients did not take their morning study medications prior to each morning FEV1 measurement. |
| Weekly Mean Evening Pre-dose Forced Expiratory Volume in One Second (FEV1) | At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication. | Weekly mean evening pre-dose Forced expiratory volume in one second (FEV1) is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements are performed individually at home and reported by the patient. It is measured by a spirometer. The best of three efforts was defined as the highest FEV1. Patients did not take their evening study medications prior to each evening FEV1 measurement. |
| Weekly Mean Number Per Day (24 Hours Period) of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI) | Weekly up to week 14: per day (24 hours period) | Weekly mean number per day of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented. Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI). |
| Weekly Mean Number at Daytime of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI) | Weekly up to week 14: at daytime (from morning dose till evening dose of study medication) | Weekly mean number at daytime of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented. Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI). |
| Weekly Mean Number at Nighttime of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI) | Weekly up to week 14: at nighttime (from evening dose till morning dose of study medication) | Weekly mean number at nighttime of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented. Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI). |
| Weekly Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Nighttime Awakenings | Per week, up to 14 weeks | Weekly mean number of chronic obstructive pulmonary disease (COPD)-related nighttime awakenings is presented. |
| Mahler Transition Dyspnoea Index (TDI) Focal Score Collected After 4, 36 and 48 Weeks Treatment Period | At week 4. | The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement). The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement. |
| Mahler Transition Dyspnoea Index (TDI) Domain Score - Functional Impairment Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period | At the end of week 4 and 12. | The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement). |
| Mahler Transition Dyspnoea Index (TDI) Domain Score - Magnitude of Task Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period | At the end of week 4 and 12. | The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. The Mahler Transition Dyspnoea Index (TDI) domain score - magnitude of task is based on the criteria of change in magnitude of task (What activities cause breathlessness now?) which causes breathlessness, ranging from grade -3 (major deterioration) to +3 (major improvement). |
| Mahler Transition Dyspnoea Index (TDI) Domain Score - Magnitude of Effort Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period | At the end of week 4 and 12. | The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. The Mahler Transition Dyspnoea Index (TDI) domain score - magnitude of effort is based on the criteria of change in magnitude of effort (Need to pause while performing activities?) which causes breathlessness, ranging from grade -3 (major deterioration) to +3 (major improvement). |
| St George Respiratory Questionnaire (SGRQ) Total Score Collected at 4, 12, 36 and 48 Weeks | At week 4 and 12. | The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. |
| St George Respiratory Questionnaire (SGRQ) Impact Domain Score Collected at 4, 12, 36 and 48 Weeks | At week 4 and 12. | The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The impact domain score is a part of the SGRQ that measures the impact of disease on daily life. Scores range from 0 to 100, with higher scores indicating more limitations. |
| St George Respiratory Questionnaire (SGRQ) Activity Domain Score Collected at 4, 12, 36 and 48 Weeks | At week 4 and 12. | The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The activity domain score is a part of the SGRQ that measures the activity of the patient. Scores range from 0 to 100, with higher scores indicating more limitations. |
| St George Respiratory Questionnaire (SGRQ) Symptoms Domain Score Collected at 4, 12, 36 and 48 Weeks | At week 4 and 12. | The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The symptoms domain score is a part of the SGRQ that measures the symptoms of the patient. Scores range from 0 to 100, with higher scores indicating more limitations. |
| Number of Patients With Adverse Events Within the 48-week Treatment Period | From randomisation till end of treatment, up to 12 weeks. | Number of patients with adverse events within the 48-week treatment period is presented. A patient may be counted in more than one seriousness criterion. |
| Number of Patients With Marked Changes in Vital Signs (Decrease) by Clinic Visit | At baseline, week 4 and week 12. | Number of patients with marked changes in vital signs (decrease) by clinic visit is presented. Vital signs: pulse rate and blood pressure (BP) (after five minutes rest in seated position) recorded pre-dose on each pulmonary function test day and in conjunction with spirometry for the first 3 hours post-dosing. Systolic BP Decrease: Below 100 mmHg if not at that level at baseline and a decrease of greater than 10 mmHg below baseline. Diastolic BP Decrease: Below 60 mmHg if not at that level at baseline and a decrease of greater than 10 mmHg below baseline. Pulse rate Decrease: Below 60 bpm if not at that level at baseline and a decrease of greater than 10 bpm below baseline. |
| Number of Patients With Marked Changes in Vital Signs (Increase) by Clinic Visit | At baseline, week 4 and week 12. | Number of patients with marked changes in vital signs (increase) by clinic visit is presented. Vital signs: pulse rate and blood pressure 8BP) (after five minutes rest in seated position) recorded pre-dose on each pulmonary function test-day and in conjunction with spirometry for the first 3 hours post-dosing. Systolic BP Increase : An increase of 25 mmHg or more above baseline. Diastolic BP Increase: Above 90 mmHg and an increase of greater than 10 mmHg above baseline. Pulse rate Increase : Greater than 100 bpm if not at that level at baseline and an increase greater than 10 % above baseline. |
| Number of Patients With Abnormal Haematology at the End of the 12-week Treatment Period | At the end of the 12-week treatment period. | Number of patients with abnormal haematology at the end of the 12-week treatment period is presented. |
| Number of Patients With Abnormal Blood Chemistry at the End of the 12-week Treatment Period | At the end of the 12-week treatment period. | Number of patients with abnormal blood chemistry at the end of the 12-week treatment period is presented. |
| Number of Patients With Abnormal Urinalysis at the End of the 12-week Treatment Period | At the end of the 12-week treatment period. | Number of patients with abnormal urinalysis at the end of the 12-week treatment period is presented. |
| Vital Status of Randomised Patients | Up to 48 weeks. | Vital status of randomised patients is presented. |
| Number of Days in Hospital Within the 48-week Treatment Period | Up to 12 weeks. | Number of days in hospital within the 48-week treatment period is presented. |
| Number of Unscheduled Health Care Provider Visits Within the 48-week Treatment Period | Up to 12 weeks. | Number of unscheduled health care provider visits within the 48-week treatment period is presented. |
| Number of Emergency Room Visits Within the 48-week Treatment Period | Up to 12 weeks. | Number of emergency room visits within the 48-week treatment period is presented. |
| Number of Days in Intensive Care Unit Within the 48-week Treatment Period | Up to 12 weeks. | Number of days in intensive care unit within the 48-week treatment period is presented. |
| Number of Patients Receiving Concomitant Medication | Up to 12 weeks. | Number of patients receiving concomitant medication is presented. Concomitant medication was observed for rerandomized placebo patients during placebo treatment and on-treatment periods. |
Countries
Austria, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Slovakia, South Africa, South Korea, Sweden, United States
Contacts
STUDY_CHAIRBoehringer Ingelheim
Boehringer Ingelheim
Participant flow
Recruitment details
24-week (+ 24 week extension) placebo-controlled (only 1st 12-week period), double-blind, parallel-group, efficacy and safety study in chronic obstructive pulmonary disease (COPD) patients. Participants randomised to the placebo arm were randomly re-assigned to one of the four active treatments after completing the 12-week period.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.4 Years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 202 Participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 43 | 0 / 45 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 3 / 41 | 7 / 43 | 5 / 45 | 6 / 43 | 3 / 43 |
| serious Total, serious adverse events | 1 / 41 | 0 / 43 | 1 / 45 | 0 / 43 | 0 / 43 |
Outcome results
None listed