Trial Outcomes & Findings for Effect of OC459 on the Response to Rhinovirus Challenge in Asthma (NCT NCT02660489)

Results Overview

Sum of daily scores for 14 days. Seven symptoms (cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness, nocturnal cough/wheeze/breathlessness) ranked from 0 (none) to 3 (severe). Range 0 to 294; higher is more symptomatic.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

During 14 days following rhinovirus inoculation

Results posted on

2021-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	OC459 (CRTH2 Antagonist) OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Overall Study STARTED	22	22
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	OC459 (CRTH2 Antagonist) OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	1	3
Overall Study no rhinovirus infection	4	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Total n=30 Participants Total of all reporting groups
Age, Continuous	25.3 years STANDARD_DEVIATION 8.9 • n=16 Participants	25.4 years STANDARD_DEVIATION 3.8 • n=14 Participants	25.3 years STANDARD_DEVIATION 6.9 • n=30 Participants
Sex: Female, Male Female	9 Participants n=16 Participants	9 Participants n=14 Participants	18 Participants n=30 Participants
Sex: Female, Male Male	7 Participants n=16 Participants	5 Participants n=14 Participants	12 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: During 14 days following rhinovirus inoculation

Sum of daily scores for 14 days. Seven symptoms (cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness, nocturnal cough/wheeze/breathlessness) ranked from 0 (none) to 3 (severe). Range 0 to 294; higher is more symptomatic.

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Total Lower Respiratory Symptom Score	21 score on a scale Interval 13.3 to 46.5	18 score on a scale Interval 9.8 to 51.5

SECONDARY outcome

Timeframe: Baseline, 10 days post rhinovirus inoculation

Change from baseline (rhinovirus inoculation, day 0) to day 10. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. The ACQ-6 asks subjects to grade their asthma control, assessed through six questions, over the previous seven days. Each question is rated on a seven-point scale ranging from 0 (well controlled) to six (extremely poorly controlled). The ACQ-6 score is the mean of the scores on the 6 items. Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Change in Asthma Control Questionnaire (ACQ)-6 Score	-0.01 score on a scale Standard Deviation 0.68	0.17 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline and up to 14 days post rhinovirus inoculation

Percentage change from baseline (rhinovirus inoculation, day 0) to trough during infection (up to day 14)

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Percentage Change in Peak Expiratory Flow Rate	-16.9 percentage change Standard Deviation 10.2	-13.1 percentage change Standard Deviation 12.8

SECONDARY outcome

Timeframe: Baseline and up to 14 days post rhinovirus inoculation

Percentage change from baseline (rhinovirus inoculation, day 0) to trough during infection (up to day 14)

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Change in Forced Expiratory Volume in 1 Second (FEV1)	-18.5 percentage change Standard Deviation 11.3	-12.7 percentage change Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline and up to 10 days post rhinovirus inoculation

Percentage change from baseline (rhinovirus inoculation, day 0) to peak during infection (highest of measurements on days 3, 5, 7, 10 post inoculation)

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Change in Exhaled Nitric Oxide (FeNO)	58 percentage change Interval 27.0 to 101.0	23 percentage change Interval 0.0 to 77.0

SECONDARY outcome

Timeframe: Baseline and 7 days post rhinovirus inoculation

Population: Two subjects (one from each group) were unable to complete PC20 at one of the time points for logistical reasons

Assessed as the provocation concentration of histamine producing a 20% fall in FEV1, or PC20 Change from baseline (rhinovirus inoculation, day 0) to day 7

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=15 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=13 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Changes in Airway Hyper Responsiveness (Histamine)	-0.1 mg/mL Interval -0.77 to 0.21	-0.64 mg/mL Interval -2.19 to -0.31

SECONDARY outcome

Timeframe: Up to 14 days post rhinovirus inoculation

Peak during infection (up to day 14)

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Viral Load (in Nasal Lavage Samples)	445861 viral copies / mL Interval 0.0 to 9025667.0	215782 viral copies / mL Interval 0.0 to 25240371.0

SECONDARY outcome

Timeframe: During 14 days following rhinovirus inoculation

Sum of daily scores for 14 days. Eight upper respiratory symptoms (sneezing; runny nose; blocked or stuffy nose; sore throat or hoarse voice; headache or face pain; generally unwell; chill, fever or shivery; cough) ranked from 0 (none) to 3 (severe). Range 0 to 336; higher is more symptomatic.

Outcome measures

Outcome measures
Measure	OC459 (CRTH2 Antagonist) n=16 Participants OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=14 Participants Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Total Upper Respiratory Symptom Score	33 score on a scale Interval 20.5 to 63.3	41 score on a scale Interval 18.5 to 63.8

Adverse Events

OC459 (CRTH2 Antagonist)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OC459 (CRTH2 Antagonist) n=22 participants at risk OC459 50mg once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16	Placebo n=22 participants at risk Placebo tablet once daily for 5 weeks Rhinovirus: Inoculation with rhinovirus serotype 16
Nervous system disorders Headache	18.2% 4/22 • Number of events 17 • 9 weeks Participants were asked to record adverse events in a study diary that was completed daily. Participants were also asked about adverse events at study visits.	9.1% 2/22 • Number of events 4 • 9 weeks Participants were asked to record adverse events in a study diary that was completed daily. Participants were also asked about adverse events at study visits.

Additional Information

Professor Sebastian Johnston

Imperial College London

Phone: +44 (0)20 7594 3764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place