Phase 4
N=200
Iota-Carrageenan Nasal Spray in Common Cold
Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT01944631 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) — 6.390; 5.777 units on a scale — p=0.0895
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Device); Iota-Carrageenan (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) |
6.390; 5.777 | 0.0895 |
| SECONDARY Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4) |
1.297; 1.121 | 0.2310 |
| SECONDARY Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4) |
5.100; 4.657 | 0.1465 |
| SECONDARY Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10) |
41.214; 41.941 | 0.8148 |
| SECONDARY Duration of the Cold |
7; 8 | 0.1887 |
| SECONDARY Patient Overall Assessment of Efficacy |
2.1; 2.0; 11.3; 16.3; 36.1; 33.7 | 0.6954 |
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)
Data sourced from ClinicalTrials.gov (NCT01944631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.