Common ColdPhase 4NCT01944631

Iota-Carrageenan Nasal Spray in Common Cold

A Phase 4 study testing Iota-Carrageenan in people with Common Cold, run by Boehringer Ingelheim at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on cold symptoms. The effect of treatment on the duration of the cold and the patients viral load plus cytokine level indicating the inflammatory response will be analyzed. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Common Cold
What is being tested?: Iota-Carrageenan
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2013to Mar 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients consider that they are in an early stage of common cold with symptoms of no more than 48 hours duration
Symptom score of equal or more than 1 for for at least one of the symptoms sore throat, runny nose and blocked nose on a 0-3 verbal rating scale
Total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal rating scale
Patients agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g. those containing zinc, Echinacea); use of a daily multivitamin is allowed.

Who cannot join

Known hypersensitivity or are allergic to any component of the test device
Clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease
Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
Taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics
Common cold or flu like symptoms for more than 48 hours.
Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom scores (analgesics, nasal decongestants, cough medicines)
Current smoker (more than 10 cigarettes a day)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

1326.1.44001 Boehringer Ingelheim Investigational Site
Cardiff

Other trials in United Kingdom

About this study

Official title: Efficacy and Safety of Iota-Carrageenan Nasal Spray 1.2 g/l (0.12 Percent) (Bisolviral) Versus Placebo Nasal Spray in the Early Treatment of Common Cold

Conditions: Common Cold
Being tested: Placebo, Iota-Carrageenan
Medical subject headings: Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDevice
Nasal spray saline
Iota-CarrageenanDevice
Nasal spray containing 1.20 g/l Iota-Carrageenan in saline

Study groups in NCT01944631
Study group	Role	What they receive
Placebo	Placebo comparator	Nasal spray 4 times a day over 4 to 10 days Receives: Device: Placebo
Iota-Carrageenan nasal spray	Experimental	Nasal spray 4 times a day over 4 to 10 days Receives: Device: Iota-Carrageenan

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)
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).
Measured: Days 2, 3 and 4

Secondary outcomes (5)

Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)
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).
Measured: Days 2, 3 and 4
Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)
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).
Measured: Days 2, 3 and 4
Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)
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).
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Duration of the Cold
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.
Measured: Baseline up to 10 days
Patient Overall Assessment of Efficacy
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).
Measured: Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Mar 2014

First posted17 Sep 2013 (estimated)
Study startSep 2013
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Common ColdStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01944631
Sponsor's protocol ID: 1326.1
Status last verified: Mar 2015
First submitted: 13 Sep 2013
Last updated: 3 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Eccles R, Winther B, Johnston SL, Robinson P, Trampisch M, Koelsch S. Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial. Respir Res. 2015 Oct 5;16:121. doi: 10.1186/s12931-015-0281-8.
PubMed 26438038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Iota-Carrageenan Nasal Spray 1.2 g/l (0.12 Percent) (Bisolviral) Versus Placebo Nasal Spray in the Early Treatment of Common Cold
ClinicalTrials.gov ID: NCT01944631
Acronym / sponsor ID: 1326.1
Conditions: Common Cold
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 17 Sep 2013 (estimated)
Results: Posted 3 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Device: PlaceboNasal spray 4 times a day over 4 to 10 days
Iota-Carrageenan nasal spray	Experimental	Device: Iota-CarrageenanNasal spray 4 times a day over 4 to 10 days

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients consider that they are in an early stage of common cold with symptoms of no more than 48 hours duration
Symptom score of equal or more than 1 for for at least one of the symptoms sore throat, runny nose and blocked nose on a 0-3 verbal rating scale
Total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal rating scale
Patients agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g. those containing zinc, Echinacea); use of a daily multivitamin is allowed.

Key exclusion criteria (8 listed)

Known hypersensitivity or are allergic to any component of the test device
Clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease
Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
Taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboNasal spray saline	Device	Placebo
Iota-CarrageenanNasal spray containing 1.20 g/l Iota-Carrageenan in saline	Device	Iota-Carrageenan nasal spray

Primary outcome

Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)
Time frame: Days 2, 3 and 4
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).

5 secondary outcomes

Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)
Time frame: Days 2, 3 and 4
Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)
Time frame: Days 2, 3 and 4
Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Duration of the Cold
Time frame: Baseline up to 10 days
Patient Overall Assessment of Efficacy
Time frame: Day 10

Results and safety

Results posted to the registry on 3 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	100	96
Bisolviral	100	98

Primary outcome: Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)

Time frame: Days 2, 3 and 4. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 97	Bisolviral n = 98
Value	6.390 (0.254)	5.777 (0.253)

Placebo vs Bisolviral: Mean Difference (Net): -0.613 (95% CI -1.321 to 0.095), p = 0.0895, ANCOVA

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first nasal spray administration until the application discontinuation date plus one day, up to 11 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 100 (0%)	0 of 100 (0%)	Not reported
Bisolviral	0 of 100 (0%)	0 of 100 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26438038Eccles R, Winther B, Johnston SL, Robinson P, Trampisch M, Koelsch S. Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial. Respir Res. 2015 Oct 5;16:121. doi: 10.1186/s12931-015-0281-8.
Related InfoLink provided by the sponsor.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Iota-Carrageenan in people with Common Cold, run by Boehringer Ingelheim at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) (time frame: Days 2, 3 and 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01944631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.