Common Cold
Conditions
Brief 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.
Detailed description
This will be a multi-center, randomized, parallel-group, double blind, 2-arm, placebo controlled study to evaluate the efficacy and safety of 1146A in adult participants with symptomatic common cold in an outpatient setting.
Interventions
DRUGCarbomer 980 (1146A)
Test product containing carbomer 980 gel
OTHERPlacebo
Reference product containing vehicle without carbomer 980 gel
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. * Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical and Investigator-led nasal examination. * Females of childbearing potential who are, in the opinion of the Investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)) OR male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant. * Investigator confirmed diagnosis of symptomatic common cold with an onset of less than 48 hours prior to randomization. Symptomatic common cold is defined as TSS \> 9 AND a score \>1 for at least one of the following symptoms: sore throat, runny nose, or blocked nose.
Exclusion criteria
* Women who have a positive urine pregnancy test. * Women who are breast-feeding. * During the entire study (Screening - last participant visit): * A. Participant who have used medications or therapies that could interfere with study evaluations and have not had the proper washout period from these medications or therapies or are anticipated to require any concomitant intranasal medication during that period or at any time throughout the study. * B. Nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities. * C. Nasal surgery or sinus surgery within the previous year. * D. Any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers). * E. Clinically relevant abnormal physical findings which, in the opinion of the Investigator or sponsor's medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures. * F. Uncontrolled cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrine, metabolic, autoimmune, neurological, psychiatric or other diseases at screening that would interfere with the study in the opinion of the Investigator. * G. Participants with seasonal allergic rhinitis if randomization occurs during their expected allergy season or perennial allergic rhinitis. * H. Severe COPD, persistent asthma, or recent COPD/asthma exacerbation. * I. An inability to comprehend and satisfactorily use the measurement instruments as determined by the study sites staff on screening. * J. Participants with a fever \> 38°C (100.4°F). * K. Frequent uses of analgesics (i.e. have taken an analgesic for pain in headache and pain in muscle/joints for at least 1 dose per week on average over the past 6 months). * Known or suspected intolerance or hypersensitivity to any of the study medications, excipients or investigational device material or to medications of similar chemical classes, any history of drug hypersensitivity or other significant allergic diathesis that could affect study participation and known or suspected contraindications, including history of allergy or photosensitivity to study medication/s. * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit or 5 half-lives of enrollment, whichever is longer and previous participation in this study (i.e. participants cannot be re-screened or randomized). Recent history (within the last 5 years) of alcohol or other substance abuse and positive urine drug screen. * An employee of the sponsor or the study sites or members of their immediate family and persons directly or indirectly involved in the execution of this protocol, including employees of the contract research organization (CRO) and persons related to them. * On nasal examination by Investigator, the presence of nasal disease likely to affect deposition of intranasal treatment or any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at the screening visit. Participants with difficulty in using the nasal spray applicator, vulnerable individual (as defined by the IRB e.g. incarcerated person) and any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | Up to Day 4 (Day 1 to 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | Up to Day 7 (Day 1 to 7) | 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 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms. |
| Average Total Symptom Score Over Days 1-4 (ATSS1-4) | Up to Day 4 (Day 1 to 4) | The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). 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):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms. |
| Average Total Symptom Score Over Days 1-7 (ATSS1-7) | Up to Day 7 (Day 1 to 7) | The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). 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):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 24 centers in United States.
Pre-assignment details
A total of 308 participants were screened for this study, out of which137 participants were screening failure.
Participants by arm
| Arm | Count |
|---|---|
| Test Product Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A). | 87 |
| Placebo Nasal Spray Participants were administered placebo nasal spray containing vehicle without carbomer 980. | 81 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Other (reason not specified) | 3 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo Nasal Spray | Total | Test Product |
|---|---|---|---|
| Age, Continuous | 50.3 Years STANDARD_DEVIATION 12.6 | 50.1 Years STANDARD_DEVIATION 13.3 | 49.8 Years STANDARD_DEVIATION 13.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 63 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 104 Participants | 51 Participants |
| Sex: Female, Male Female | 56 Participants | 113 Participants | 57 Participants |
| Sex: Female, Male Male | 25 Participants | 55 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 81 |
| other Total, other adverse events | 32 / 87 | 34 / 81 |
| serious Total, serious adverse events | 1 / 87 | 0 / 81 |
Outcome results
Primary
Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)
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.
Time frame: Up to Day 4 (Day 1 to 4)
Population: Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | 3.428 Score on a scale | Standard Deviation 1.4784 |
| Placebo Nasal Spray | Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | 3.336 Score on a scale | Standard Deviation 1.6917 |
p-value: 0.51695% CI: [-0.279, 0.553]ANCOVA
Secondary
Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)
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 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.
Time frame: Up to Day 7 (Day 1 to 7)
Population: Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | 2.700 Score on a scale | Standard Deviation 1.3142 |
| Placebo Nasal Spray | Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | 2.651 Score on a scale | Standard Deviation 1.5455 |
Secondary
Average Total Symptom Score Over Days 1-4 (ATSS1-4)
The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). 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):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.
Time frame: Up to Day 4 (Day 1 to 4)
Population: Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Average Total Symptom Score Over Days 1-4 (ATSS1-4) | 7.811 Score on a scale | Standard Deviation 3.1962 |
| Placebo Nasal Spray | Average Total Symptom Score Over Days 1-4 (ATSS1-4) | 7.754 Score on a scale | Standard Deviation 3.4996 |
Secondary
Average Total Symptom Score Over Days 1-7 (ATSS1-7)
The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). 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):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.
Time frame: Up to Day 7 (Day 1 to 7)
Population: Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Average Total Symptom Score Over Days 1-7 (ATSS1-7) | 6.171 Score on a scale | Standard Deviation 2.9822 |
| Placebo Nasal Spray | Average Total Symptom Score Over Days 1-7 (ATSS1-7) | 6.195 Score on a scale | Standard Deviation 3.2078 |