A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Overview
- Phase
- Phase 4
- Intervention
- tiotropium inhalation
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 2488
- Locations
- 222
- Primary Endpoint
- Time to First Moderate or Severe On-treatment COPD Exacerbation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Intervention: tiotropium inhalation
fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Intervention: salmeterol xinafoate
fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Intervention: fluticasone propionate
fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Intervention: tiotropium inhalation
fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Intervention: salmeterol xinafoate
fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Intervention: fluticasone propionate
fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Intervention: placebo matched for fluticasone propionate
Outcomes
Primary Outcomes
Time to First Moderate or Severe On-treatment COPD Exacerbation
Time Frame: During randomised treatment, up to 488 days
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.
Secondary Outcomes
- Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation(During randomised treatment, up to 488 days)
- Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.(During randomised treatment, up to 488 days)
- Number of On-treatment COPD Exacerbations(During randomised treatment, up to 488 days)
- Severity of On-treatment COPD Exacerbations(During randomised treatment, up to 488 days)
- Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale(Baseline and week 18 and 52 visits)
- Number of Moderate or Severe On-treatment COPD Exacerbations(During randomised treatment, up to 488 days)
- Time to First On-treatment COPD Exacerbation(During randomised treatment, up to 488 days)
- Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)(Baseline and week 18 and 52 visits)
- Change in On-treatment Lung Function as Measured by Trough FEV1(Baseline and week 6, 12, 18 and 52 visits)
- Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain(Baseline and week 12, 18 and 52 visits)
- Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain(Baseline and week 12, 18 and 52 visits)
- Time to First Severe On-treatment COPD Exacerbation(During randomised treatment, up to 488 days)
- Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain(Baseline and week 27 and 52 visits)
- Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain(Baseline and week 27 and 52 visits)
- Number of Severe On-treatment COPD Exacerbations(During randomised treatment, up to 488 days)
- Proportion of Patients With at Least One On-treatment COPD Exacerbation(During randomised treatment, up to 488 days)
- Change in On-treatment BODE Index(Baseline and week 18 and 52 visits)
- Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain(Baseline and week 12, 18 and 52 visits)
- Change in On-treatment FVC as Measured by Home Based Spirometry(Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits)
- Change in On-treatment PEFR as Measured by Home Based Spirometry(Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits)
- Change in On-treatment Physician Global Evaluation(Baseline and week 27 and 52 visits)
- Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)(Baseline and week 18 and 52 visits)
- Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain(Baseline and week 12, 18 and 52 visits)
- Change in On-treatment FEV1 as Measured by Home Based Spirometry(Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits)
- Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain(Baseline and week 27 and 52 visits)
- Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score(Baseline and week 27 and 52 visits)