Study 117106: Mepolizumab vs. Placebo as add-on treatment for frequently exacerbating COPD patients

Not Applicable

• Conditions: -J44 Other chronic obstructive pulmonary disease; Other chronic obstructive pulmonary disease; J44

• Registration Number: PER-013-14
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

1. COPD diagnosis: Subjects with a clinically documented history of COPD for at least 1 year in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]
2. Severity of COPD: Subjects must present with the following:
• A measured pre and post-salbutamol FEV1/FVC ratio of <0.70 at Visit 1 to confirm the diagnosis of COPD
• A measured post-salbutamol FEV1> 20% and ≤80% of predicted normal values calculated using NHANES III reference equations [Hankinson 1999, Hankinson, 2010] at Visit 1
3. History of exacerbations: A well documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of:
• at least two moderate COPD exacerbations. Moderate is defined as the use of systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or treatment with antibiotics.
OR
• at least one severe COPD exacerbation. Severe is defined as having required hospitalization
Note: At least one exacerbation must have occurred while the subject was taking ICS plus LABA plus LAMA.
Note: Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD.
4. Concomitant COPD therapy: A well documented requirement for optimized standard of care (SoC) background therapy that includes ICS plus 2 additional COPD medications (i.e., triple therapy) for the 12 months prior to Visit 1 and meets the following criteria

Exclusion Criteria

1. Asthma:
•Current and Former Smokers: Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD)
•Never-Smokers: Subjects with any history of asthma
2. Other respiratory disorders: The investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Subjects with α1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also, excluded are subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. Subjects are also excluded if maintenance use of bi-level positive airway pressure is required for the treatment of respiratory disorder. 3. COPD stability: Subjects with pneumonia, exacerbation, lower respiratory infection within the 4 weeks prior to Visit 1. 4. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
5. Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
6. Oxygen: Subjects receiving treatment with oxygen more than 4.0L/min. While breathing supplemental oxygen, subjects should demonstrate an oxyhemoglobin saturation greater than or equal to 89%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified