Clinical trial NCT01944631: Iota-Carrageenan Nasal Spray in Common Cold
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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)

Primary outcomes:
measure: Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)
timeFrame: Days 2, 3 and 4
Secondary outcomes:
measure: Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)
timeFrame: Days 2, 3 and 4
measure: Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)
timeFrame: Days 2, 3 and 4
measure: Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)
timeFrame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
measure: Duration of the Cold
timeFrame: Baseline up to 10 days
measure: Patient Overall Assessment of Efficacy
timeFrame: Day 10
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: 1326.1.44001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.