Iota-Carrageenan Nasal Spray in Common Cold

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Common Cold

Treatments

Device: Placebo

Device: Iota-Carrageenan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01944631

1326.1

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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)