Trial Outcomes & Findings for Mepolizumab in Chronic Obstructive Pulmonary Diseases (COPD) With Eosinophilic Bronchitis (NCT NCT01463644)

Last Updated: 2025-09-24

Results Overview

The results will be expressed as absolute changes in percent sputum eosinophil counts from baseline to end of therapy (at 6 months). Change is difference in sputum eosinophils between baseline/time zero to end of therapy/6 months. A larger number represents a greater degree in the reduction of sputum eosinophils.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

6 months

Results posted on

2025-09-24

Participant Flow

Patients who met eligibility criteria after the screening visit entered a 24 week double-blind treatment period followed by one follow-up visit.

Eligible adult patients were enrolled by baseline post-bronchodilator FEV1/VC\<70% and post bronchodilator FEV1 \<60% predicted), greater than 10 pack years and sputum eosinophils greater than/equal to 3%. Patients were then randomized to either mepolizumab 750 mg every 4 weeks (Q4W) or matched placebo in a 1:1 ratio.

Participant milestones

Participant milestones
Measure	Mepolizumab Mepolizumab: This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.	Placebo placebo: The placebo consisted of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).
Overall Study STARTED	8	10
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Scores were available in 4 and 5 participants in mepolizumab and placebo groups respectively

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepolizumab n=8 Participants Mepolizumab: This is an anti interleukin-5 (IL-5) which is given once a month intravenously at the dose of 750 mg.	Placebo n=10 Participants placebo: The placebo consisted of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).	Total n=18 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 6.31 • n=8 Participants	67 years STANDARD_DEVIATION 5.89 • n=10 Participants	66 years STANDARD_DEVIATION 5.97 • n=18 Participants
Sex: Female, Male Female	4 Participants n=8 Participants	1 Participants n=10 Participants	5 Participants n=18 Participants
Sex: Female, Male Male	4 Participants n=8 Participants	9 Participants n=10 Participants	13 Participants n=18 Participants
Total cell count/g of sputum	4.10 cells per gram of sputum n=8 Participants	11.6 cells per gram of sputum n=10 Participants	8.20 cells per gram of sputum n=18 Participants
Sputum eosinophil count (%)	11 percentage of eosinophils n=8 Participants	7.35 percentage of eosinophils n=10 Participants	10.10 percentage of eosinophils n=18 Participants
Sputum neutrophil count (%)	54.5 percentage STANDARD_DEVIATION 15.2 • n=8 Participants	70.9 percentage STANDARD_DEVIATION 15.7 • n=10 Participants	63.6 percentage STANDARD_DEVIATION 17.22 • n=18 Participants
Blood eosinophil count	0.69 cells/mm^3 STANDARD_DEVIATION 0.50 • n=8 Participants	0.33 cells/mm^3 STANDARD_DEVIATION 0.29 • n=10 Participants	0.5 cells/mm^3 STANDARD_DEVIATION 0.42 • n=18 Participants
Pre bronchodilator forced expiratory volume in 1 second (FEV1)	1.35 forced expiratory volume in litres STANDARD_DEVIATION 0.49 • n=8 Participants	0.99 forced expiratory volume in litres STANDARD_DEVIATION 0.28 • n=10 Participants	1.10 forced expiratory volume in litres STANDARD_DEVIATION 0.42 • n=18 Participants
Pre bronchodilator FEV1%	55.00 percentage n=8 Participants	29.50 percentage n=10 Participants	34.00 percentage n=18 Participants
Post bronchodilator FEV1	1.53 litres STANDARD_DEVIATION 0.57 • n=8 Participants	1.24 litres STANDARD_DEVIATION 0.52 • n=10 Participants	1.40 litres STANDARD_DEVIATION 0.54 • n=18 Participants
Postbronchodilator FEV1%	58.50 percentage n=8 Participants	35.00 percentage n=10 Participants	45.00 percentage n=18 Participants
Pre bronchodilator slow vital capacity (SVC)	2.69 litres STANDARD_DEVIATION 0.68 • n=8 Participants	2.85 litres STANDARD_DEVIATION 0.46 • n=10 Participants	2.80 litres STANDARD_DEVIATION 0.56 • n=18 Participants
Post bronchodilator SVC	2.79 litres STANDARD_DEVIATION 0.74 • n=8 Participants	3.09 litres STANDARD_DEVIATION 0.76 • n=10 Participants	3.00 litres STANDARD_DEVIATION 0.75 • n=18 Participants
Post bronchodilator FEV1/SVC	55.11 percentage n=8 Participants	37.21 percentage n=10 Participants	44.00 percentage n=18 Participants
Total Lung Capacity (TLC)	5.20 litres STANDARD_DEVIATION 0.85 • n=8 Participants	6.60 litres STANDARD_DEVIATION 1.01 • n=10 Participants	5.90 litres STANDARD_DEVIATION 1.16 • n=18 Participants
Residual Volume (RV)	2.36 litres STANDARD_DEVIATION 0.56 • n=8 Participants	3.39 litres STANDARD_DEVIATION 0.77 • n=10 Participants	2.90 litres STANDARD_DEVIATION 0.84 • n=18 Participants
Diffusion capacity (DLCO)	14.92 ml CO/min/mmHg STANDARD_DEVIATION 4.67 • n=8 Participants	14.39 ml CO/min/mmHg STANDARD_DEVIATION 4.54 • n=10 Participants	14.60 ml CO/min/mmHg STANDARD_DEVIATION 4.47 • n=18 Participants
COPD Assessment test (CAT) scores	16 units on a scale n=4 Participants • Scores were available in 4 and 5 participants in mepolizumab and placebo groups respectively	25 units on a scale n=5 Participants • Scores were available in 4 and 5 participants in mepolizumab and placebo groups respectively	23 units on a scale n=9 Participants • Scores were available in 4 and 5 participants in mepolizumab and placebo groups respectively
Chronic Respiratory Questionnaire (CRQ) scores	93.75 units on a scale STANDARD_DEVIATION 18.75 • n=8 Participants	82.7 units on a scale STANDARD_DEVIATION 21.16 • n=10 Participants	87.60 units on a scale STANDARD_DEVIATION 20.34 • n=18 Participants
Sputum hyaluronan	466 ng/ml n=8 Participants	517 ng/ml n=10 Participants	517 ng/ml n=18 Participants
Sputum versican	3.74 ng/ml n=8 Participants	3.55 ng/ml n=10 Participants	3.57 ng/ml n=18 Participants
Proportion of Patients With a Major Exacerbation	4 Participants n=8 Participants	7 Participants n=10 Participants	11 Participants n=18 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Mepolizumab n=8 Participants Mepolizumab: This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.	Placebo n=10 Participants placebo: The placebo consisted of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).
Percentage Decrease of Sputum Eosinophils From Baseline to End of Therapy (6 Months)	11.28 percentage Standard Deviation 6.60	7.07 percentage Standard Deviation 11.49

SECONDARY outcome

Timeframe: Baseline to 6 months

Exacerbation: a sustained worsening of the patient's respiratory condition, from the stable state and beyond normal day-to-day variations, necessitating a change in regular medication in a patient with underlying COPD Major exacerbation will be defined as a symptomatic deterioration requiring treatment with antibiotics, oral or intravenous corticosteroids, hospitalization, or a combination of these.

Outcome measures

Outcome measures
Measure	Mepolizumab n=8 Participants Mepolizumab: This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.	Placebo n=10 Participants placebo: The placebo consisted of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).
Proportion of Patients With a Major Exacerbation.	4 participants	7 participants

Adverse Events

Mepolizumab

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mepolizumab n=8 participants at risk Mepolizumab: This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.	Placebo n=10 participants at risk placebo: The placebo consisted of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).
Cardiac disorders Myocardial infarction	12.5% 1/8 • Number of events 1 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.	0.00% 0/10 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.
Musculoskeletal and connective tissue disorders C3 distal humeral fracture with a left trochlear fracture	12.5% 1/8 • Number of events 1 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.	0.00% 0/10 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders COPD exacerbation - hospital admission	0.00% 0/8 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.	10.0% 1/10 • Number of events 1 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.

Other adverse events

Other adverse events
Measure	Mepolizumab n=8 participants at risk Mepolizumab: This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.	Placebo n=10 participants at risk placebo: The placebo consisted of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).
Renal and urinary disorders Urinary tract infection	12.5% 1/8 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.	0.00% 0/10 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Infective bronchitis	37.5% 3/8 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.	40.0% 4/10 • Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months). The safety analysis set comprised all patients who received at least one dose of study treatment. Patients were classified according to the treatment they actually received.

Additional Information

Dr. Parameswaran Nair

McMaster University

Phone: 905-522-1155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place