A Phase 4 interventional study of tiotropium inhalation and salmeterol xinafoate in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 222 sites in 23 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-02-10.
Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment
This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 2,488 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Drug: tiotropium inhalation · Drug: salmeterol xinafoate · Drug: fluticasone propionate
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Drug: tiotropium inhalation · Drug: salmeterol xinafoate · Drug: fluticasone propionate · Drug: placebo matched for fluticasone propionate
Time to First Moderate or Severe On-treatment COPD Exacerbation
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.
Time frame: During randomised treatment, up to 488 days
Number of Moderate or Severe On-treatment COPD Exacerbations
Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. Measured values show adjusted mean event rate.
Time frame: During randomised treatment, up to 488 days
Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation
Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
Time frame: During randomised treatment, up to 488 days
Time to First Severe On-treatment COPD Exacerbation
Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. The "measure type" displays the 25th percentile and its 95% confidence interval.
Time frame: During randomised treatment, up to 488 days
Number of Severe On-treatment COPD Exacerbations
Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Measured values show adjusted event rate.
Time frame: During randomised treatment, up to 488 days
Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
Time frame: During randomised treatment, up to 488 days
Time to First On-treatment COPD Exacerbation
Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.
Time frame: During randomised treatment, up to 488 days
Number of On-treatment COPD Exacerbations
Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined. Measured values show adjusted event rate.
Time frame: During randomised treatment, up to 488 days
Proportion of Patients With at Least One On-treatment COPD Exacerbation
Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.
Time frame: During randomised treatment, up to 488 days
Severity of On-treatment COPD Exacerbations
Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)
Time frame: During randomised treatment, up to 488 days
Change in On-treatment Lung Function as Measured by Trough FEV1
Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 6, 12, 18 and 52 visits
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health. Scale from 0 to 4: * 0 = not troubled by breathlessness, except during strenuous exercise * 1 = short of breath when hurrying or walking up a slight hill * 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace * 3 = stops for breath after approximately 100 yards, or after a few minutes on the level * 4 = too breathless to leave the house, or breathless when dressing or undressing "No breathlessness" was given a score of -1 Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment BODE Index
Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 12, 18 and 52 visits
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment FVC as Measured by Home Based Spirometry
Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment PEFR as Measured by Home Based Spirometry
Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 27 and 52 visits
Change in On-treatment Physician Global Evaluation
Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Time frame: Baseline and week 27 and 52 visits
| Milestone | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Started | 1244 | 1244 |
| Completed | 1016 | 1011 |
| Not completed | 228 | 233 |
| Withdrew: Adverse event | 108 | 101 |
| Withdrew: Lack of efficacy | 6 | 6 |
| Withdrew: Protocol violation | 27 | 23 |
| Withdrew: Lost to follow-up | 9 | 7 |
| Withdrew: Withdrawal by subject | 48 | 61 |
| Withdrew: Other reason not defined above | 29 | 33 |
| Withdrew: Not treated | 1 | 2 |
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.
| days | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Time to First Moderate or Severe On-treatment COPD Exacerbation | 107.0 (94.0 to 124.0) | 110.0 (99.0 to 120.0) |
Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. Measured values show adjusted mean event rate.
| exacerbations per patient-year | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Number of Moderate or Severe On-treatment COPD Exacerbations | 0.91 (0.83 to 0.99) | 0.95 (0.87 to 1.04) |
Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
| percentage of participants | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation | 44.2 | 46.7 |
Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. The "measure type" displays the 25th percentile and its 95% confidence interval.
| days | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Time to First Severe On-treatment COPD Exacerbation | NA (NA to NA) | 419.0 (379.0 to NA) |
Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Measured values show adjusted event rate.
| exacerbations per patient-year | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Number of Severe On-treatment COPD Exacerbations | 0.20 (0.17 to 0.23) | 0.23 (0.19 to 0.27) |
Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
| percentage of participants | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation. | 13.4 | 15.2 |
Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.
| days | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Time to First On-treatment COPD Exacerbation | 365.0 (309.0 to NA) | 346.0 (302.0 to NA) |
Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined. Measured values show adjusted event rate.
| exacerbations per patient-year | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Number of On-treatment COPD Exacerbations | 1.03 (0.95 to 1.12) | 1.08 (0.99 to 1.17) |
Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.
| percentage of participants | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Proportion of Patients With at Least One On-treatment COPD Exacerbation | 46.9 | 49.0 |
Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)
| percentage of participants | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| None and patient completed randomised treatment | 42.9 | 41.2 |
| None and patient discontinued randomised treatment | 10.2 | 9.8 |
| Mild | 2.7 | 2.3 |
| Moderate | 30.8 | 31.5 |
| Severe | 13.4 | 15.2 |
Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| Litres | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 6 visit (N=1135, 1135) | -0.009 ± 0.0062 | -0.011 ± 0.0062 |
| Week 12 visit (N=1114, 1092) | -0.011 ± 0.0062 | -0.018 ± 0.0063 |
| Week 18 visit (N=1077, 1058) | -0.011 ± 0.0064 | -0.050 ± 0.0064 |
| Week 52 visit (N=970, 935) | -0.016 ± 0.0094 | -0.059 ± 0.0096 |
Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health. Scale from 0 to 4: * 0 = not troubled by breathlessness, except during strenuous exercise * 1 = short of breath when hurrying or walking up a slight hill * 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace * 3 = stops for breath after approximately 100 yards, or after a few minutes on the level * 4 = too breathless to leave the house, or breathless when dressing or undressing "No breathlessness" was given a score of -1 Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 18 visit (N=1140, 1143) | -0.030 ± 0.022 | -0.001 ± 0.022 |
| Week 52 visit (N=1043, 1019) | -0.028 ± 0.024 | 0.035 ± 0.024 |
Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| kg/m2 | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 18 visit (N=1143, 1146) | 0.030 ± 0.028 | 0.040 ± 0.028 |
| Week 52 visit (N=1047, 1021) | 0.004 ± 0.039 | -0.009 ± 0.039 |
Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| meters | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 18 visit (N=1111, 1110) | 3.89 ± 1.993 | 1.94 ± 1.993 |
| Week 52 visit (N=1013, 987) | 3.94 ± 2.231 | 0.42 ± 2.252 |
Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 18 visit (N=1038, 1024) | -0.06 ± 0.03 | 0.06 ± 0.03 |
| Week 52 visit (N=931, 907) | -0.03 ± 0.04 | 0.14 ± 0.04 |
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 12 visit (N=307, 319) | -1.65 ± 0.986 | -1.24 ± 0.968 |
| Week 18 visit (N=302, 312) | -2.87 ± 1.035 | -3.71 ± 1.018 |
| Week 52 visit (N=268, 269) | -4.51 ± 1.063 | -5.54 ± 1.057 |
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 12 visit (N=309, 318) | -0.32 ± 1.062 | -0.85 ± 1.048 |
| Week 18 visit (N=305, 312) | -1.47 ± 1.103 | -3.34 ± 1.091 |
| Week 52 visit (N=270, 268) | -1.69 ± 1.180 | -3.26 ± 1.180 |
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 12 visit (N=308, 317) | -2.26 ± 0.996 | -1.63 ± 0.983 |
| Week 18 visit (N=303, 310) | -2.38 ± 0.977 | -3.31 ± 0.967 |
| Week 52 visit (N=267, 267) | -4.29 ± 1.047 | -4.15 ± 1.045 |
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 12 visit (N=308, 317) | -1.36 ± 1.154 | -1.24 ± 1.139 |
| Week 18 visit (N=302, 311) | -2.71 ± 1.119 | -1.93 ± 1.105 |
| Week 52 visit (N=269, 268) | -5.10 ± 1.212 | -2.45 ± 1.211 |
Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| Litres | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 6 visit (N=893, 939) | -0.049 ± 0.0066 | -0.053 ± 0.0065 |
| Week 12 visit (N=910, 930) | -0.050 ± 0.0068 | -0.056 ± 0.0067 |
| Week 18 visit (N=913, 901) | -0.051 ± 0.0068 | -0.093 ± 0.0068 |
| Week 27 visit (N=863, 843) | -0.056 ± 0.0071 | -0.092 ± 0.0072 |
| Week 36 visit (N=854, 845) | -0.059 ± 0.0074 | -0.099 ± 0.0074 |
| Week 45 visit (N=830, 815) | -0.061 ± 0.0080 | -0.103 ± 0.0080 |
| Week 52 visit (N=785, 788) | -0.067 ± 0.0087 | -0.115 ± 0.0087 |
Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| Litres | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 6 visit (N=893, 939) | -0.116 ± 0.0179 | -0.089 ± 0.0177 |
| Week 12 visit (N=910, 930) | -0.113 ± 0.0168 | -0.105 ± 0.0167 |
| Week 18 visit (N=913, 901) | -0.122 ± 0.0177 | -0.124 ± 0.0177 |
| Week 27 visit (N=863, 843) | -0.123 ± 0.0167 | -0.147 ± 0.0167 |
| Week 36 visit (N=854, 845) | -0.135 ± 0.0170 | -0.158 ± 0.0171 |
| Week 45 visit (N=830, 815) | -0.141 ± 0.0174 | -0.168 ± 0.0175 |
| Week 52 visit (N=785, 788) | -0.157 ± 0.0180 | -0.201 ± 0.0180 |
Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| Litres/sec | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 6 visit (N=893, 939) | -0.228 ± 0.0249 | -0.230 ± 0.0246 |
| Week 12 visit (N=910, 930) | -0.266 ± 0.0253 | -0.290 ± 0.0252 |
| Week 18 visit (N=913, 901) | -0.295 ± 0.0253 | -0.435 ± 0.0254 |
| Week 27 visit (N=863, 843) | -0.319 ± 0.0273 | -0.430 ± 0.0274 |
| Week 36 visit (N=854, 845) | -0.352 ± 0.0278 | -0.473 ± 0.0278 |
| Week 45 visit (N=830, 815) | -0.368 ± 0.0297 | -0.490 ± 0.0298 |
| Week 52 visit (N=785, 788) | -0.377 ± 0.0318 | -0.538 ± 0.0318 |
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 27 visit (N=1002, 988) | 0.09 ± 0.492 | 0.85 ± 0.496 |
| Week 52 visit (N=942, 916) | -0.19 ± 0.512 | 0.78 ± 0.518 |
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 27 visit (N=1004, 998) | -0.78 ± 0.456 | 0.35 ± 0.457 |
| Week 52 visit (N=946, 921) | -0.08 ± 0.494 | 1.27 ± 0.499 |
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 27 visit (N=1010, 998) | 0.12 ± 0.583 | 0.62 ± 0.586 |
| Week 52 visit (N=955, 921) | 0.51 ± 0.593 | 1.11 ± 0.602 |
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 27 visit (N=996, 986) | -0.42 ± 0.398 | 0.55 ± 0.401 |
| Week 52 visit (N=939, 913) | -0.07 ± 0.432 | 1.15 ± 0.437 |
Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
| units on a scale | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Week 27 visit (N=1113, 1093) | 0.10 ± 0.03 | 0.04 ± 0.03 |
| Week 52 visit (N=1041, 1014) | 0.19 ± 0.03 | 0.08 ± 0.03 |
Collected over Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone Maintenance | — | 292/1,243 (23.5%) | 464/1,243 (37.3%) |
| Fluticasone Withdrawal | — | 300/1,242 (24.2%) | 458/1,242 (36.9%) |
| Event | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 154/1243 | 180/1242 |
| PneumoniaInfections and infestations | 34/1243 | 38/1242 |
| Lobar pneumoniaInfections and infestations | 12/1243 | 3/1242 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 9/1243 | 10/1242 |
| Atrial fibrillationCardiac disorders | 9/1243 | 5/1242 |
| Infective exacerbation of chronic obstructive airways diseaseInfections and infestations | 7/1243 | 5/1242 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/1243 | 5/1242 |
| Acute myocardial infarctionCardiac disorders | 5/1243 | 1/1242 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/1243 | 3/1242 |
| Cardiac arrestCardiac disorders | 3/1243 | 4/1242 |
| Event | Fluticasone Maintenance | Fluticasone Withdrawal |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 410/1243 | 413/1242 |
| NasopharyngitisInfections and infestations | 93/1243 | 80/1242 |
Treated Set (TS) which included all patients who were dispensed study medication and were documented to have taken ≥1 dose of randomised treatment.
| Age, Continuous(years) | Fluticasone Maintenance | Fluticasone Withdrawal | Total |
|---|---|---|---|
| Mean | 63.6 ± 8.6 | 64.0 ± 8.4 | 63.8 ± 8.5 |
| Sex: Female, Male(Participants) | Fluticasone Maintenance | Fluticasone Withdrawal | Total |
|---|---|---|---|
| Female | 230 | 206 | 436 |
| Male | 1013 | 1036 | 2049 |
Showing the first 100 of 222 sites across 23 countries.
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Boehringer Ingelheim