Trial Outcomes & Findings for Iota-Carrageenan Nasal Spray in Common Cold (NCT NCT01944631)

Results Overview

The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms. Each common cold symptom was scored on a 4-point ordinal scale: * 0 = symptom not present * 1 = mild symptom (I can feel it but it has not disturbed or irritated me) * 2 = moderate symptom (symptom has disturbed and irritated me some of the time) * 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

Days 2, 3 and 4

Results posted on

2015-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Overall Study STARTED	100	100
Overall Study COMPLETED	96	98
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Iota-Carrageenan Nasal Spray in Common Cold

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=100 Participants Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral n=100 Participants Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Total n=200 Participants Total of all reporting groups
Age, Continuous	19.93 years STANDARD_DEVIATION 1.90 • n=5 Participants	20.01 years STANDARD_DEVIATION 2.37 • n=7 Participants	19.97 years STANDARD_DEVIATION 2.14 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	60 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 2, 3 and 4

Population: Full analysis set (FAS) which included all randomised patients who used at least one dose of trial treatment, who provided a baseline total symptom score (TSS) as well as any post-treatment data for the primary endpoint.

The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms. Each common cold symptom was scored on a 4-point ordinal scale: * 0 = symptom not present * 1 = mild symptom (I can feel it but it has not disturbed or irritated me) * 2 = moderate symptom (symptom has disturbed and irritated me some of the time) * 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms).

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral n=98 Participants Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)	6.390 units on a scale Standard Error 0.254	5.777 units on a scale Standard Error 0.253

SECONDARY outcome

Timeframe: Days 2, 3 and 4

Population: FAS

The mean of the sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness). Each common cold symptom was scored on a 4-point ordinal scale: * 0 = symptom not present * 1 = mild symptom (I can feel it but it has not disturbed or irritated me) * 2 = moderate symptom (symptom has disturbed and irritated me some of the time) * 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean of the sum of 3 single systemic common cold symptom scores over days 2-4 was calculated as (SSS2 + SSS3 + SSS4)/3 where SSS2, SSS3 and SSS4 are the systemic common cold symptom scores calculated for days 2, 3 and 4 respectively. SSS2-4 ranges from 0 (no symptoms) to 9 (severe symptoms).

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral n=98 Participants Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)	1.297 units on a scale Standard Error 0.103	1.121 units on a scale Standard Error 0.103

SECONDARY outcome

Timeframe: Days 2, 3 and 4

Population: FAS

The mean of the sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing). Each common cold symptom was scored on a 4-point ordinal scale: * 0 = symptom not present * 1 = mild symptom (I can feel it but it has not disturbed or irritated me) * 2 = moderate symptom (symptom has disturbed and irritated me some of the time) * 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean of the sum of 5 single local common cold symptom scores over days 2 to 4 was calculated as (LSS2 + LSS3 + LSS4)/3 where LSS2, LSS3 and LSS4 are the local common cold symptom scores calculated for days 2, 3 and 4 respectively. LSS2-4 ranges from 0 (no symptoms) to 15 (severe symptoms).

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral n=98 Participants Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)	5.100 units on a scale Standard Error 0.215	4.657 units on a scale Standard Error 0.214

SECONDARY outcome

Timeframe: Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10

Population: FAS

The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms. Each common cold symptom was scored on a 4-point ordinal scale: * 0 = symptom not present * 1 = mild symptom (I can feel it but it has not disturbed or irritated me) * 2 = moderate symptom (symptom has disturbed and irritated me some of the time) * 3 = severe symptom (symptom has disturbed and irritated me most of the time) The Area under the curve (AUC) over the 10-day period for the total symptom score (AUC-TSS 1-10) was calculated as the sum of the TSS calculated on each day from day 1 to day 10. AUC-TSS 1-10 ranges from 0 (no symptoms) to 270 (severe symptoms).

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral n=98 Participants Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)	41.214 units on a scale * days Standard Error 2.199	41.941 units on a scale * days Standard Error 2.187

SECONDARY outcome

Timeframe: Baseline up to 10 days

Population: FAS

Duration of the common cold was assessed by the question "Do you still have a cold?" at the end of each treatment day. The duration of the cold was defined as ended by the first day of a "No" answer to this daily question.

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral n=98 Participants Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Duration of the Cold	7 days Interval 7.0 to 8.0	8 days Interval 7.0 to 9.0

SECONDARY outcome

Timeframe: Day 10

Population: FAS

Patient overall assessment of efficacy was assessed by the question "How effective was the treatment in relieving your common cold symptoms?" at day 10. A 5-point scale was used (0=poor, 1=fair, 2=good, 3=very good, 4=excellent).

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.	Bisolviral n=98 Participants Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
Patient Overall Assessment of Efficacy Excellent	2.1 percentage of participants	2.0 percentage of participants
Patient Overall Assessment of Efficacy Very good	11.3 percentage of participants	16.3 percentage of participants
Patient Overall Assessment of Efficacy Good	36.1 percentage of participants	33.7 percentage of participants
Patient Overall Assessment of Efficacy Fair	33.0 percentage of participants	28.6 percentage of participants
Patient Overall Assessment of Efficacy Poor	17.5 percentage of participants	19.4 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bisolviral

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER