CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 171 enrolled
Drug / intervention
Carbomer 980 (1146A) +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 18–75 years
  • ✓Investigator-confirmed symptomatic common cold with symptom onset <48 hours prior to randomization
  • ✓TSS >9 and score >1 for at least one of: sore throat, runny nose, or blocked nose
  • ✓Good general and mental health with no clinically significant abnormalities in medical history or physical examination
Key exclusion· 10
  • ✕Nasal disease likely to affect intranasal medication deposition (chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities)
  • ✕Nasal or sinus surgery within the previous year
  • ✕Inability to actuate nasal spray devices (severe rheumatoid arthritis, deformed hands and fingers, missing fingers)
  • ✕Seasonal allergic rhinitis during expected allergy season or perennial allergic rhinitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03005067
NCT03005067Phase 2Completed
CompareCT.gov

A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Subjects With Symptoms of Common Cold

GlaxoSmithKline·interventional·Posted Dec 29, 2016·Updated Jun 19, 2018

In Brief

A Phase 2 clinical trial evaluating Carbomer 980 (1146A) and Placebo for Common Cold. Completed, enrolled 171 participants across 24 sites.

Detailed Summary

This study will be conducted in adult participants with symptoms of common cold assessing if 1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo. The study will also evaluate the safety of 1146A compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCommon Cold
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 29, 2016
Enrollment StartDec 29, 2016
Primary CompletionJun 7, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.5 years ago

Interventions

Carbomer 980 (1146A)drug

Test product containing carbomer 980 gel

Placeboother

Reference product containing vehicle without carbomer 980 gel