Iota-Carrageenan Nasal Spray in Common Cold

NCT ID: NCT01944631

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-03-31

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Nasal spray 4 times a day over 4 to 10 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Nasal spray saline

Iota-Carrageenan nasal spray

Nasal spray 4 times a day over 4 to 10 days

Group Type: EXPERIMENTAL

Iota-Carrageenan

Intervention Type: DEVICE

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

Interventions

Placebo

Nasal spray saline

Intervention Type: DEVICE

Iota-Carrageenan

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1326.1.44001 Boehringer Ingelheim Investigational Site

Cardiff, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26438038 (View on PubMed)

Other Identifiers

1326.1

Identifier Type: -

Identifier Source: org_study_id