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Also known as Carbomer 980 (1146A)
Carbomer 980 · 2 trials · 1 indication
The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.
The investigators will perform a thorough examination using nasal mucosal grading scale: Grade 0 = No abnormal findings, Grade 1A = focal nasal mucosal irritation (inflammation, erythema or hyperemia), Grade 1B = superficial nasal mucosal erosion, Grade 2 = moderate nasal mucosal erosion
The investigators will perform a thorough examination using mucosal bleeding scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
The investigators will perform a thorough examination using crusting of mucosa scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
| Arm | Type | Description |
|---|---|---|
| Carbomer 980 (1146A) | EXPERIMENTAL | Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL. |
| Carbomer 980 | EXPERIMENTAL | Participants will be administered test product (nasal spray) containing 0.5% carbomer 980, 4 times per day (i.e. 3 actuations per nostril per dose; each actuation will be 140 mcL, equivalent to 140 mg). |
| Name | Type | Description |
|---|---|---|
| Carbomer 980 (1146A) | DRUG | Test product containing carbomer 980 gel |
| Placebo | OTHER | Reference product containing vehicle without carbomer 980 gel |
| Carbomer 980 | DRUG | Test product containing 0.5% carbomer 980 gel |
Inclusion Criteria: * Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Aged between 18 to 75 years inclusive. * Male or female. ...
Carbomer 980 is being developed as a nasal spray treatment for symptoms of the common cold. It is an investigational small molecule studied in adult participants aged 18 years and older. GSK plc is the developer. It has been tested in two completed clinical trials, one Phase 2 efficacy and safety study and one Phase 1 tolerability study.
Carbomer 980 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical program evaluating the nasal spray in adults with common cold symptoms. GSK holds the development program for this asset.
Carbomer 980 is in Phase 2 development. The Phase 2 trial, NCT03005067, evaluated efficacy and safety in adults with common cold symptoms and is completed. An earlier Phase 1 local nasal tolerability and safety study, NCT02832362, in healthy adults is also completed. No active trials are currently listed.
Carbomer 980 has been studied in two completed trials. NCT03005067 was a Phase 2 randomized, double-blind, placebo-controlled study of 1146A nasal spray in 171 adults with common cold symptoms in the United States. NCT02832362 was a Phase 1 local nasal tolerability and safety study in 30 healthy adults in Canada.
Yes, Carbomer 980 is also known as Carbomer 980 (1146A). The designation 1146A appears in the trial titles for the nasal spray formulation studied in common cold. Both names refer to the same investigational asset developed by GSK plc.
Carbomer 980 is investigational and has not been approved. It remains in clinical development, with Phase 2 and Phase 1 trials completed. The program includes a randomized, double-blind, placebo-controlled Phase 2 study in adults with common cold symptoms and a Phase 1 tolerability study in healthy adults.