Common ColdPhase 1NCT02832362
Local Nasal Tolerability and Safety Study of 1146A in Healthy Adult Participants
A Phase 1 study testing Carbomer 980 in people with Common Cold, run by GlaxoSmithKline at 1 site in Canada.
Trial summary
This will be a single-center, randomized, parallel-group, placebo-controlled study to assess the local nasal tolerability and safety of multiple administrations of topically (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- Carbomer 980
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2016to 18 Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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. Willing to be confined for 9 days (8 nights) and acceptance of standardized food and beverages throughout the confined study period
- Aged between 18 and 55 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 nasal examinations
- Participant is free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
- 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
Who cannot join
- Women who have a positive urine pregnancy test
- Women who are breast-feeding
- History of malignancy or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases, clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study, History (within 5 years prior to study start) or any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric or other diseases at screening, participants 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, any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers), Nasal disease(s) likely to affect deposition of intranasal medication, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities
- Known or suspected intolerance or hypersensitivity to any of the study medications, excipients, investigational device material, or to medications of similar chemical classes, any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis, 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 screening or 5 half-lives of the other clinical studies investigational drug, whichever is longer, Previously enrolled in the current study
- Current smoker or smoked or used nicotine containing products within 5 years of screening, history (within 5 years prior to study start) or evidence of illicit drug abuse or if the investigator suspects current drug use with drug classes that include but are not limited to barbiturates, amphetamines, benzodiazepines, cocaine, opiates, cannabis or any other illicit drugs (verified by urine drug screening or other reliable evidence), history or evidence of current alcohol abuse or if participant reports a regular average alcohol consumption exceeding 18 g (women) or 35 g (men) of pure alcohol per day, i.e. 1 drink/day for women or 2 drinks/day for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening
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- Non-acceptance of standardized food and beverages throughout each confined study period, Ingestion of food containing poppy seeds (muffins, bagels, cakes, etc) within 24 hours of admission to the study site
- Persons directly or indirectly involved in the execution of this protocol, including employees of the contract research organization (CRO) and persons related to them, an employee of the sponsor or the study site or members of their immediate family
- On nasal examination, the presence of any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1B - 4) during the screening visit or Day -1, Participants with difficulty in using the nasal spray applicator, "Vulnerable" individual (as defined by the Institutional Review Board (IRB) e.g. incarcerated person), 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, no consumption of alcohol-containing products within 24 hours before confinement and throughout confined study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Local Nasal Tolerability and Safety of 1146A in Healthy Adult Subjects
This will be a single-center, randomized, parallel-group, placebo-controlled study to assess the local nasal tolerability and safety of multiple administrations of topically (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult participants
- Conditions
- Common Cold
- Being tested
- Carbomer 980, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbomer 980Drug
Test product containing 0.5% carbomer 980 gel
PlaceboOther
Reference product containing vehicle without 0.5% carbomer 980 gel
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Carbomer 980 |
| Placebo | Placebo comparator | Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980, 4 times per day (i.e. 3 actuations per nostril per dose; each actuation will be 140 mcL, equivalent to 140 mg). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of nasal mucosal changes of ≥ Grade 1B
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
Measured: Baseline to Day 8
Incidence of moderate or severe mucosal bleeding
The investigators will perform a thorough examination using mucosal bleeding scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Measured: Baseline to Day 8
Incidence of moderate or severe crusting of mucosa
The investigators will perform a thorough examination using crusting of mucosa scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Measured: Baseline to Day 8
Secondary outcomes (11)
Adverse events
All adverse events reported by participants will be recorded.
Measured: Baseline to Day 8
Change from baseline in Blood pressure
Systolic and diastolic BP will be measured three times after the participant has been sitting for 5 minutes using an automated validated device, e.g. OMRON, with an appropriately sized cuff. The repeat sitting measurements will be made at 1-2 minute intervals and the mean/average of the three measurements will be recorded.
Measured: Baseline to Day 8
Change from baseline in pulse
Pulse will be measured three times after the participant has been sitting for 5 minutes using an automated validated device, e.g. OMRON, with an appropriately sized cuff. The repeat sitting measurements will be made at 1-2 minute intervals and the mean/average of the three measurements will be recorded.
Measured: Baseline to Day 8
Change from baseline in respiration rate
The rate will be measured by counting the number of breaths for one minute (counting how many times the chest rises).
Measured: Baseline to Day 8
Change from baseline in oral body temperature
Oral body temperature will be measured. Reference range (Oral body temperature between 35.0 º Celsius (C) and 37.5 ºC)
Measured: Baseline to Day 8
Change from baseline in Hematology
Hemoglobin (Hb), hematocrit (Ht), red blood cell (RBC) count (including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), white blood cell (WBC) count with differential and platelet count will be measured.
Measured: Baseline to Day 8
Change from baseline in clinical Chemistry
Electrolytes (sodium, potassium, chloride, calcium, phosphorous), substrates (Blood Urea Nitrogen [BUN], creatinine, total bilirubin, total protein, albumin, uric acid, and C-reactive protein), and enzymes (aspartate amino transferase [AST], alanine amino transferase [ALT], alkaline phosphatase (ALP), gamma glutamyl transferase [GGT], creatine kinase [CK]) will be measured.
Measured: Baseline to Day 8
Change from baseline in virus Serology
Serology will be performed only for Hepatitis B Surface Antigen (HBs Ag), Hepatitis B core antibody [anti-HBc] (Immunoglobulin G [IgG] + Immunoglobulin M [IgM]), anti-HCV Ab [Hepatitis C Virus antibody], Human Immunodeficiency Virus [HIV] 1 and HIV 2 antibodies.
Measured: Baseline to Day 8
Change from baseline in urinalysis
Specific gravity, nitrite, protein including microalbuminuria, glucose, ketones as well as blood WBC and RBC sediments will be assessed. (
Measured: Baseline to Day 8
Change from baseline in urine drug & cotinine screen
: Urine will be collected and tested for cotinine and the following drugs or illicit substances: barbiturates, benzodiazepines, amphetamines, cocaine, opiates, and cannabis.
Measured: Baseline to Day 8
Change from baseline in pregnancy and assessments of fertility
A urine dipsick test will be performed.
Measured: Baseline to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start11 Jun 2016
- Primary completion10 Jul 2016
- Study completion18 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832362
- Sponsor's protocol ID
- 205636
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Local Nasal Tolerability and Safety of 1146A in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02832362
- Acronym / sponsor ID
- 205636
- Conditions
- Common Cold
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2016 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 18 Jul 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-center, randomized, parallel-group, placebo-controlled study to assess the local nasal tolerability and safety of multiple administrations of topically (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult participants
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbomer 980 | Experimental | Drug: Carbomer 980Participants 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). |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be administered reference product (nasal spray) containing vehicle without carbomer 980, 4 times per day (i.e. 3 actuations per nostril per dose; each actuation will be 140 mcL, equivalent to 140 mg). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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. Willing to be confined for 9 days (8 nights) and acceptance of standardized food and beverages throughout the confined study period
- Aged between 18 and 55 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 nasal examinations
- Participant is free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
Key exclusion criteria (9 listed)
- Women who have a positive urine pregnancy test
- Women who are breast-feeding
- History of malignancy or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases, clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study, History (within 5 years prior to study start) or any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric or other diseases at screening, participants 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, any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers), Nasal disease(s) likely to affect deposition of intranasal medication, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities
- Known or suspected intolerance or hypersensitivity to any of the study medications, excipients, investigational device material, or to medications of similar chemical classes, any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis, 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 screening or 5 half-lives of the other clinical studies investigational drug, whichever is longer, Previously enrolled in the current study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbomer 980Test product containing 0.5% carbomer 980 gel | Drug | Carbomer 980 |
| PlaceboReference product containing vehicle without 0.5% carbomer 980 gel | Other | Placebo |
Primary outcome
Incidences of nasal mucosal changes of ≥ Grade 1B
Time frame: Baseline to Day 8
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
Incidence of moderate or severe mucosal bleeding
Time frame: Baseline to Day 8
The investigators will perform a thorough examination using mucosal bleeding scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Incidence of moderate or severe crusting of mucosa
Time frame: Baseline to Day 8
The investigators will perform a thorough examination using crusting of mucosa scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
11 secondary outcomes
Adverse events
Time frame: Baseline to Day 8
Change from baseline in Blood pressure
Time frame: Baseline to Day 8
Change from baseline in pulse
Time frame: Baseline to Day 8
Change from baseline in respiration rate
Time frame: Baseline to Day 8
Change from baseline in oral body temperature
Time frame: Baseline to Day 8
Change from baseline in Hematology
Time frame: Baseline to Day 8
Change from baseline in clinical Chemistry
Time frame: Baseline to Day 8
Change from baseline in virus Serology
Time frame: Baseline to Day 8
Change from baseline in urinalysis
Time frame: Baseline to Day 8
Change from baseline in urine drug & cotinine screen
Time frame: Baseline to Day 8
Change from baseline in pregnancy and assessments of fertility
Time frame: Baseline to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Results for Study 205636 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carbomer 980 in people with Common Cold, run by GlaxoSmithKline at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of nasal mucosal changes of ≥ Grade 1B (time frame: Baseline to Day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.