Trial Outcomes & Findings for Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases (NCT NCT04765722)

NCT ID: NCT04765722

Last Updated: 2025-09-16

Results Overview

Change from baseline in 24-hour cough frequency (coughs/hour) measured by the VitaloJAK cough monitor at 14 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 46 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2025-09-16

Participant Flow

Participant milestones

Measure	Mepolizumab Arm Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases

Baseline characteristics by cohort

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1 ml pre-filled syringe Dosage: 100 mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.09% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Total n=30 Participants Total of all reporting groups
Age, Continuous	65.87 Years STANDARD_DEVIATION 9.72 • n=5 Participants	65.80 Years STANDARD_DEVIATION 13.93 • n=7 Participants	65.83 Years STANDARD_DEVIATION 11.80 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Cough Duration (months)	120 Months n=5 Participants	61 Months n=7 Participants	115.5 Months n=5 Participants
Diagnosis Non-asthmatic eosinophilic bronchitis	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Diagnosis Asthma	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
% Sputum Eosinophils	2.6 Percentage n=5 Participants	2.6 Percentage n=7 Participants	2.6 Percentage n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in 24-hour cough frequency (coughs/hour) measured by the VitaloJAK cough monitor at 14 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in 24-hour Cough Frequency at 14 Weeks Week 0	17.0 Coughs/hour Interval 16.7 to 17.3	17.0 Coughs/hour Interval 16.7 to 17.3
Change From Baseline in 24-hour Cough Frequency at 14 Weeks Week 14	12.6 Coughs/hour Interval 8.2 to 19.3	10.6 Coughs/hour Interval 7.6 to 15.0

SECONDARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in awake cough frequency (coughs/hour) measured by the VitaloJAK cough monitor at 8 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Awake Cough Frequency at 8 Weeks Week 0	22.5 Coughs/hour Interval 22.4 to 22.6	22.5 Coughs/hour Interval 22.5 to 22.6
Change From Baseline in Awake Cough Frequency at 8 Weeks Week 8	17.8 Coughs/hour Interval 13.8 to 23.0	12.5 Coughs/hour Interval 10.8 to 14.6

SECONDARY outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in awake cough frequency (coughs/hour) at 14 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Awake Cough Frequency at 14 Weeks Week 0	22.5 Coughs/hour Interval 22.4 to 22.6	22.5 Coughs/hour Interval 22.5 to 22.6
Change From Baseline in Awake Cough Frequency at 14 Weeks Week 14	16.3 Coughs/hour Interval 10.6 to 25.1	14.1 Coughs/hour Interval 9.7 to 20.4

SECONDARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in sleep cough frequency (coughs/hour) measured by the VitaloJAK cough monitor at 8 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Sleep Cough Frequency at 8 Weeks Week 0	1.8 Coughs/hour Interval 1.5 to 2.3	1.7 Coughs/hour Interval 1.3 to 2.2
Change From Baseline in Sleep Cough Frequency at 8 Weeks Week 8	1.0 Coughs/hour Interval 0.5 to 2.1	1.4 Coughs/hour Interval 0.7 to 2.8

SECONDARY outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in sleep cough frequency (coughs/hour) measured by the VitaloJAK cough monitor at 14 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Sleep Cough Frequency at 14 Weeks Week 0	1.8 Coughs/hour Interval 1.5 to 2.3	1.7 Coughs/hour Interval 1.3 to 2.2
Change From Baseline in Sleep Cough Frequency at 14 Weeks Week 14	1.9 Coughs/hour Interval 0.9 to 4.0	1.5 Coughs/hour Interval 0.9 to 2.4

SECONDARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in cough severity measured on the 100-mm visual analogue scale at 8 weeks. Scale ranges from 0 mm (no cough) to 100 mm (worst possible cough). Higher scores reflect worse cough severity.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Cough Severity at 8 Weeks Week 0	65.3 mm Interval 62.1 to 68.5	63.9 mm Interval 60.7 to 67.0
Change From Baseline in Cough Severity at 8 Weeks Week 8	55.7 mm Interval 45.4 to 66.0	49.3 mm Interval 41.9 to 56.8

SECONDARY outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in cough severity measured on the 100-mm visual analogue scale at 14 weeks. Scale ranges from 0 mm (no cough) to 100 mm (worst possible cough). Higher scores reflect worse cough severity.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Cough Severity at 14 Weeks Week 0	65.3 mm Interval 62.1 to 68.5	63.9 mm Interval 60.7 to 67.0
Change From Baseline in Cough Severity at 14 Weeks Week 14	49.5 mm Interval 35.9 to 63.1	51.4 mm Interval 40.8 to 62.0

SECONDARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in cough quality of life measured by the Leicester Cough Questionnaire at 8 weeks. Total score ranges from 3 to 21, with higher scores indicating better cough quality of life.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline on the Leicester Cough Questionnaire at 8 Weeks Week 0	11.3 points Interval 10.8 to 11.8	11.1 points Interval 10.5 to 11.6
Change From Baseline on the Leicester Cough Questionnaire at 8 Weeks Week 8	11.6 points Interval 10.0 to 13.2	13.7 points Interval 12.4 to 14.9

SECONDARY outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in cough quality of life measured by the Leicester Cough Questionnaire at 14 weeks. Total score ranges from 3 to 21, with higher scores indicating better cough quality of life.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline on the Leicester Cough Questionnaire at 14 Weeks Week 0	11.3 points Interval 10.8 to 11.8	11.1 points Interval 10.5 to 11.6
Change From Baseline on the Leicester Cough Questionnaire at 14 Weeks Week 14	12.8 points Interval 11.1 to 14.6	13.7 points Interval 12.3 to 15.0

SECONDARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in blood eosinophils at 8 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Blood Eosinophils at 8 Weeks Week 0	284.2 cells/µL Interval 256.1 to 312.2	288.9 cells/µL Interval 259.1 to 318.8
Change From Baseline in Blood Eosinophils at 8 Weeks Week 8	57.5 cells/µL Interval 19.4 to 95.6	282.2 cells/µL Interval 191.0 to 373.6

SECONDARY outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in blood eosinophils at 14 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Blood Eosinophils at 14 Weeks Week 0	284.2 cells/µL Interval 256.1 to 312.2	288.9 cells/µL Interval 259.1 to 318.8
Change From Baseline in Blood Eosinophils at 14 Weeks Week 14	44.2 cells/µL Interval 4.0 to 84.3	281.9 cells/µL Interval 242.9 to 320.9

SECONDARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in sputum eosinophils (%) at 8 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Sputum Eosinophils at 8 Weeks Week 0	2.9 % sputum eosinophils Interval 2.4 to 3.4	2.8 % sputum eosinophils Interval 2.4 to 3.2
Change From Baseline in Sputum Eosinophils at 8 Weeks Week 8	1.8 % sputum eosinophils Interval 1.3 to 2.6	2.8 % sputum eosinophils Interval 2.0 to 3.8

SECONDARY outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in sputum eosinophils (%) at 14 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Sputum Eosinophils at 14 Weeks Week 0	2.9 % sputum eosinophils Interval 2.4 to 3.4	2.8 % sputum eosinophils Interval 2.4 to 3.2
Change From Baseline in Sputum Eosinophils at 14 Weeks Week 14	1.6 % sputum eosinophils Interval 1.0 to 2.4	2.6 % sputum eosinophils Interval 1.7 to 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

Population: All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.

Change from baseline in methacholine provocative concentration eliciting a 20% fall in FEV1 (PC20) at 14 weeks.

Outcome measures

Measure	Mepolizumab Arm n=15 Participants Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 Participants Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Change From Baseline in Methacholine Provocative Concentration Eliciting a 20% Fall in FEV1 (PC20) at 14 Weeks Week -2	14.4 mg/mL Interval 12.4 to 16.4	13.1 mg/mL Interval 11.1 to 15.1
Change From Baseline in Methacholine Provocative Concentration Eliciting a 20% Fall in FEV1 (PC20) at 14 Weeks Week 14	15.8 mg/mL Interval 9.1 to 22.5	24.3 mg/mL Interval 19.1 to 29.5

Adverse Events

Mepolizumab Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mepolizumab Arm n=15 participants at risk Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Mepolizumab: Mepolizumab subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.	Placebo Arm n=15 participants at risk Normal Saline (0.9% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks Normal Saline: Placebo subcutaneous injection administered 4 times days 0, 28, 56 and 84 during 12 week treatment period.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	26.7% 4/15 • 14 weeks All adverse events were reported.	40.0% 6/15 • 14 weeks All adverse events were reported.

Additional Information

Dr. Imran Satia

McMaster University

Phone: 905 5212100

Email: satiai@mcmaster.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place