Trial Outcomes & Findings for A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection (NCT NCT01175226)

Results Overview

Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

300 participants

Primary outcome timeframe

Days 2-4

Results posted on

2018-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	BTA798 BTA798: BTA798 twice daily	Placebo Placebo: Placebo twice daily
Overall Study STARTED	155	145
Overall Study COMPLETED	144	140
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BTA798 n=154 Participants BTA798: BTA798 twice daily	Placebo n=145 Participants Placebo: Placebo twice daily	Total n=299 Participants Total of all reporting groups
Age, Continuous	40.6 years STANDARD_DEVIATION 14.34 • n=5 Participants	42.0 years STANDARD_DEVIATION 13.69 • n=7 Participants	41.3 years STANDARD_DEVIATION 14.02 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	95 Participants n=7 Participants	209 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	50 Participants n=7 Participants	90 Participants n=5 Participants
Region of Enrollment United States	154 participants n=5 Participants	145 participants n=7 Participants	299 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 2-4

Population: Intent-to-Treat Infected (ITT-I) Population - all randomized subjects who had a PCR positive result for rhinovirus from nasal swab on Days 1, 3, 5 and 7 with at least 1 post-baseline measurement of efficacy.

Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.

Outcome measures

Outcome measures
Measure	BTA798 n=42 Participants BTA798: BTA798 twice daily	Placebo n=50 Participants Placebo: Placebo twice daily
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire	-9.12 Scores on a scale Standard Error 1.403	-5.11 Scores on a scale Standard Error 1.184

Adverse Events

BTA798

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BTA798 n=154 participants at risk BTA798: BTA798 twice daily	Placebo n=145 participants at risk Placebo: Placebo twice daily
Nervous system disorders Headache	4.5% 7/154 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.	4.1% 6/145 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.
Infections and infestations Upper Respiratory Tract Infection	3.2% 5/154 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.	3.4% 5/145 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.
Infections and infestations Sinusitis	3.2% 5/154 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.	2.8% 4/145 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.
Respiratory, thoracic and mediastinal disorders Asthma	3.2% 5/154 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.	2.1% 3/145 Adverse events are reported for the Safety Population defined as all randomized subjects who met the eligibility criteria and were randomized.

Additional Information

Anna Novotney-Barry

Aviragen Therapeutics, Inc.

Phone: 678-221-3356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place