Trial · NCT03005067
To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold
NCT03005067, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold. Trials, record NCT03005067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03005067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold
- NCT number
- NCT03005067
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 171 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Common Cold
- Interventions
- Carbomer 980 (1146A), Placebo
- First posted
- 2016-12-29
- Last updated
- 2018-06-19
- Results first posted
- 2018-06-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | Up to Day 4 (Day 1 to 4) | 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. | Score on a scale | MEAN |
| SECONDARY | Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | Up to Day 7 (Day 1 to 7) | 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. | Score on a scale | MEAN |
| SECONDARY | Average Total Symptom Score Over Days 1-4 (ATSS1-4) | Up to Day 4 (Day 1 to 4) | 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. | Score on a scale | MEAN |
| SECONDARY | Average Total Symptom Score Over Days 1-7 (ATSS1-7) | Up to Day 7 (Day 1 to 7) | 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. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | Test Product | 3.428 | Standard Deviation 1.4784 | Score on a scale | |
| Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) | Placebo Nasal Spray | 3.336 | Standard Deviation 1.6917 | Score on a scale | |
| Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | Test Product | 2.700 | Standard Deviation 1.3142 | Score on a scale | |
| Average Nasal Symptom Score Over Days 1-7 (ANSS1-7) | Placebo Nasal Spray | 2.651 | Standard Deviation 1.5455 | Score on a scale | |
| Average Total Symptom Score Over Days 1-4 (ATSS1-4) | Test Product | 7.811 | Standard Deviation 3.1962 | Score on a scale | |
| Average Total Symptom Score Over Days 1-4 (ATSS1-4) | Placebo Nasal Spray | 7.754 | Standard Deviation 3.4996 | Score on a scale | |
| Average Total Symptom Score Over Days 1-7 (ATSS1-7) | Test Product | 6.171 | Standard Deviation 2.9822 | Score on a scale | |
| Average Total Symptom Score Over Days 1-7 (ATSS1-7) | Placebo Nasal Spray | 6.195 | Standard Deviation 3.2078 | Score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Product | 90 | |
| Overall Study | STARTED | Placebo Nasal Spray | 81 | |
| Overall Study | COMPLETED | Test Product | 80 | |
| Overall Study | COMPLETED | Placebo Nasal Spray | 74 | |
| Overall Study | NOT COMPLETED | Test Product | 10 | |
| Overall Study | NOT COMPLETED | Placebo Nasal Spray | 7 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Test Product | 5 | 87 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Placebo Nasal Spray | 1 | 81 | |
| other | EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Test Product | 2 | 87 | |
| other | EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Placebo Nasal Spray | 4 | 81 | |
| other | NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Test Product | 3 | 87 | |
| other | NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Placebo Nasal Spray | 2 | 81 | |
| other | OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Test Product | 3 | 87 | |
| other | OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Placebo Nasal Spray | 2 | 81 | |
| other | RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | Test Product | 4 | 87 | |
| other | RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | Placebo Nasal Spray | 1 | 81 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Product | 0 | 87 |
| Total, all-cause mortality | Placebo Nasal Spray | 0 | 81 |
| Total, other adverse events | Test Product | 32 | 87 |
| Total, other adverse events | Placebo Nasal Spray | 34 | 81 |
| Total, serious adverse events | Test Product | 1 | 87 |
| Total, serious adverse events | Placebo Nasal Spray | 0 | 81 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Test Product vs Placebo Nasal Spray: deaths from any cause | Trial comparisons |
| Test Product vs Placebo Nasal Spray: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03005067
GET https://conductscience.org/api/trials/v1/NCT03005067/events?page=2