Asthma and RhinitisPhase 2NCT01607372
A Study to Investigate the Safety and Pharmacodynamics of Repeat Intranasal Administration of the TLR7 Agonist GSK2245035 in Subjects With Respiratory Allergies
A Phase 2 study testing GSK2245035 and Type 1 amber glass bottle in people with Asthma and Rhinitis, run by GlaxoSmithKline at 1 site in Canada.
Trial summary
GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates preferentially the induction of type I interferons. Intranasal (i.n.) administration of GSK2245035 in humans causes immune changes in the upper airways milieu that may alter bystander immune responsiveness to aeroallergens and… Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma and Rhinitis
- What is being tested?
- GSK2245035 and Type 1 amber glass bottle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Sep 2013
- Phase
- Phase 2
- 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 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health, as determined by a responsible and experienced physician, based on a medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Males between 18 and 62 years of age inclusive.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until four days after the last dosing.
- Females between 18 and 62 years of age inclusive, if they are of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal, defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 147 pmol/L) is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Body weight greater than and equal to 50 kilogram (kg) and body mass index (BMI) within the range 19 - 35 kg/meter square (m^2) (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Available to complete all required study measurements.
- Documented history of Symptomatic perennial allergic rhinitis and mild asthma driven by house dust mite (HDM) for more than 3 years, that does not require regular use of inhaled steroids. Subjects with symptomatic perennial allergic rhinitis and mild asthma driven by house dust mite (HDM) will need to have a positive skin allergy test (wheal ≥ 3 millimeter [mm]) or RAST (≥ class 2) to house dust mite allergens. (However, an allergen radio allergosorbent test [RAST] or skin test can be omitted if a subject provides clear evidence confirmed by a physician of an analogous positive test within the last 3 years).
Who cannot join
- History of immunological disorders or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator and GSK medical monitor may pose additional risk factors
- Nasal conditions that according to the opinion of the investigator may affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds.
- Respiratory tract infection within 4 weeks prior to the first dosing.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody
- A positive screening or pre-dose drug/alcohol screen
Show all 21Show fewer
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 14 drinks for males or greater than 7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 millileter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- Participation in a clinical trial with receipt of an investigational product within 3 months prior to the first dosing day.
- Exposure to more than four new chemical entities within 6 months prior to the first dosing day.
- History of drug or other allergy that, in the opinion of the investigator or GSK medical monitor, contraindicates participation in this study.
- Donation of blood or blood products in excess of 500 mL within a 56-day period.
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of severe asthma
- Serious asthma exacerbation requiring hospital visit and/ or treatment with oral steroids or high doses of inhaled steroids within 6 weeks prior to screening
- History of treatment with allergen-specific immunotherapy
- Pre-bronchodilator FEV1 less than and equal to 70% of predicted at screening
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to first dosing, unless in the opinion of the investigator and GlaxoSmithKline (GSK) medical monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol is an exception and will be permitted at daily doses of up to 4 g from screening to follow-up. During the dosing visits Paracetamol can be used, if needed, only if the investigator allows it.
- Subjects using steroid treatment for allergic rhinitis and/or asthma may participate in the study if they can remain free of medication throughout the study period starting from the following periods of time prior to first dosing: Nasal steroids: 4 weeks; Oral steroids: 12 weeks; Inhaled steroids: 4 weeks
- Subjects using other medications for their allergic rhinitis and/or asthma on an as needed basis may participate in the study if they can abstain from: Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates, leukotriene antagonists, 5-lipoxygenase inhibitors and longacting inhaled beta-agonists from 1 week prior to screening and throughout the study Na; Nasal antihistamines: 48 hours prior each dosing; Oral antihistamines: 76 hours prior each dosing; Nasal decongestants: 24 hours prior each dosing; Oral decongestants: 24 hours prior each dosing; Short acting inhaled beta-agonists: 48 hours prior each dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Study to Investigate the Safety and Pharmacodynamics of Repeat Intranasal Administration of the TLR7 Agonist GSK2245035 in Subjects With Respiratory Allergies
GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates preferentially the induction of type I interferons. Intranasal (i.n.) administration of GSK2245035 in humans causes immune changes in the upper airways milieu that may alter bystander immune responsiveness to aeroallergens and contribute to reduction of allergic reactivity in subjects with respiratory allergies. The purpose of this study is to examine the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with respiratory allergies. The safety and pharmacodynamic response of four weekly administrations of escalating doses of i.n. GSK2245035 will be investigated and the maximum tolerated dose will be established. The study will be conducted in patients with symptomatic allergic rhinitis and mild asthma. The overall duration of the study will be up to a maximum of approximately 122 days considering 90 days screening period, 22 days treatment period and 10 days follow-up period.
- Conditions
- Asthma and Rhinitis
- Being tested
- GSK2245035, Type 1 amber glass bottle, Placebo
- Keywords
- TLR7 agonist, Respiratory Allergies, Allergic Rhinitis, Mild Allergic Asthma, Repeat Dose Safety, Reduction of Allergic Reactivity
- Medical subject headings
- Asthma, Rhinitis, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2245035Drug
GSK2245035 nasal spray solution. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate
Type 1 amber glass bottleDevice
fitted with a metered Valios VP7 pump
PlaceboOther
As for GSK2245035 nasal spray solution except for omission of the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| GSK2245035 - 40 ng or placebo | Experimental | Subjects will receive GSK2245035 - 40 nanogram (ng) or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. Receives: Drug: GSK2245035; Device: Type 1 amber glass bottle; Other: Placebo |
| GSK2245035 - 80 ng or placebo | Experimental | Subjects will receive GSK2245035 - 80 ng or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. Receives: Drug: GSK2245035; Device: Type 1 amber glass bottle; Other: Placebo |
| GSK2245035 - 120 ng or placebo | Experimental | Subjects will receive GSK2245035 - 120 ng or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. Receives: Drug: GSK2245035; Device: Type 1 amber glass bottle; Other: Placebo |
| GSK2245035 - 160 ng or placebo | Experimental | Subjects will receive GSK2245035 - 160 ng or placebo once per week, for four treatment weeks. There will be washout period of 7 days between treatment periods. Receives: Drug: GSK2245035; Device: Type 1 amber glass bottle; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing adverse events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 122 Days
Hematology parameters as a safety measure
The hematology parameters included are platelet count, red blood cell (RBC) count, white blood cell (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils.
Measured: Up to 112 Days
Clinical Chemistry parameters as a safety measure
Clinical chemistry parameters included are blood urea nitrogen (BUN), creatinine, glucose, potassium, C-Reactive protein (CRP) potassium, chloride, total carbon dioxide, calcium, total and direct bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), alkaline phosphatase, uric acid, protein and albumin
Measured: Up to 112 Days
Urinalysis parameters as a safety measure
Urinalysis parameters included are specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick, microscopic examination (if blood or protein is abnormal)
Measured: Up to 112 Days
Body temperature
Measured: Up to 112 Days
Systolic and diastolic blood pressure (BP)
Measured: Up to 112 Days
Pulse rate
Measured: Up to 112 Days
ECG parameters
A 12 lead electrocardiogram (ECG) will be measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Measured: Up to 112 Days
Nasal examination
Visual nasal examination will be conducted by a trained physician
Measured: Up to 112 Days
Nasal symptoms assessment
Nasal tolerability symptoms itching, discomfort, post-nasal drip, rhinorrhoea, obstruction will be assessed using a Visual analogue score system
Measured: Up to 23 Days
Secondary outcomes (10)
FEV1 assessment
To evaluate the effect of four repeat doses of i.n. GSK2245035 administered once per week on lung function, as measured by Forced expiratory volume in one second FEV1
Measured: Up to 112 Days
TLR7-induced blood PD biomarkers, including TLR7-induced cytokines
To evaluate the induction of TLR7-associated blood PD biomarkers following administration of i.n. GSK2245035 once per week
Measured: Up to 23 Days
TLR7-induced nasal PD biomarkers, including but not limited to induced protein (IP)-10, i.n. nasal lavage fluid
To evaluate the induction of TLR7-associated nasal PD biomarkers following administration of repeat doses of i.n. GSK2245035 once per week
Measured: Up to 23 Days
Daily rhinitis symptoms and use of medication diaries during the study period
Measured: Up to 122 Days
Daily asthma symptoms and use of medication diaries during the study period
Measured: Up to 122 Days
Daily morning peak expiratory flow (PEF) during the study period
Measured: Up to 112 Days
Exhaled NO assessment
Measured: Up to 23 Days
Cell counts and differential in nasal lavage
Measured: Up to 23 Days
Exploratory allergic biomarkers including but not limited to immunoglobulins and cytokines in blood and nasal lavage fluid and tissue
Measured: Up to 23 Days
Plasma GSK2245035 concentrations
Measured: Up to 23 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma and RhinitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607372
- Sponsor's protocol ID
- 116392
- Status last verified
- Jan 2017
- First submitted
- 29 Mar 2012
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Tsitoura D, Ambery C, Price M, Powley W, Garthside S, Biggadike K, Quint D. Early clinical evaluation of the intranasal TLR7 agonist GSK2245035: Use of translational biomarkers to guide dosing and confirm target engagement. Clin Pharmacol Ther. 2015 Oct;98(4):369-80. doi: 10.1002/cpt.157.
PubMed 26044169
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Study to Investigate the Safety and Pharmacodynamics of Repeat Intranasal Administration of the TLR7 Agonist GSK2245035 in Subjects With Respiratory Allergies
- ClinicalTrials.gov ID
- NCT01607372
- Acronym / sponsor ID
- 116392
- Conditions
- Asthma and Rhinitis
- Keywords
- TLR7 agonist, Respiratory Allergies, Allergic Rhinitis, Mild Allergic Asthma, Repeat Dose Safety, Reduction of Allergic Reactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 May 2012 (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.
GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates preferentially the induction of type I interferons. Intranasal (i.n.) administration of GSK2245035 in humans causes immune changes in the upper airways milieu that may alter bystander immune responsiveness to aeroallergens and contribute to reduction of allergic reactivity in subjects with respiratory allergies. The purpose of this study is to examine the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with respiratory allergies. The safety and pharmacodynamic response of four weekly administrations of escalating doses of i.n. GSK2245035 will be investigated and the maximum tolerated dose will be established. The study will be conducted in patients with symptomatic allergic rhinitis and mild asthma. The overall duration of the study will be up to a maximum of approximately 122 days considering 90 days screening period, 22 days treatment period and 10 days follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GSK2245035 - 40 ng or placebo | Experimental | Drug: GSK2245035, Device: Type 1 amber glass bottle, Other: PlaceboSubjects will receive GSK2245035 - 40 nanogram (ng) or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. |
| GSK2245035 - 80 ng or placebo | Experimental | Drug: GSK2245035, Device: Type 1 amber glass bottle, Other: PlaceboSubjects will receive GSK2245035 - 80 ng or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. |
| GSK2245035 - 120 ng or placebo | Experimental | Drug: GSK2245035, Device: Type 1 amber glass bottle, Other: PlaceboSubjects will receive GSK2245035 - 120 ng or placebo once per week for four treatment weeks. There will be washout period of 7 days between treatment periods. GSK medical monitor will review all available clinical and laboratory safety data and decide if subjects can proceed to the next scheduled dosing cohort. |
| GSK2245035 - 160 ng or placebo | Experimental | Drug: GSK2245035, Device: Type 1 amber glass bottle, Other: PlaceboSubjects will receive GSK2245035 - 160 ng or placebo once per week, for four treatment weeks. There will be washout period of 7 days between treatment periods. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Good general health, as determined by a responsible and experienced physician, based on a medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Males between 18 and 62 years of age inclusive.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until four days after the last dosing.
- Females between 18 and 62 years of age inclusive, if they are of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal, defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 147 pmol/L) is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Body weight greater than and equal to 50 kilogram (kg) and body mass index (BMI) within the range 19 - 35 kg/meter square (m^2) (inclusive).
Key exclusion criteria (21 listed)
- History of immunological disorders or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator and GSK medical monitor may pose additional risk factors
- Nasal conditions that according to the opinion of the investigator may affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds.
- Respiratory tract infection within 4 weeks prior to the first dosing.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody
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 |
|---|---|---|
| GSK2245035GSK2245035 nasal spray solution. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate | Drug | GSK2245035 - 120 ng or placebo, GSK2245035 - 160 ng or placebo, GSK2245035 - 40 ng or placebo, GSK2245035 - 80 ng or placebo |
| Type 1 amber glass bottlefitted with a metered Valios VP7 pump | Device | GSK2245035 - 120 ng or placebo, GSK2245035 - 160 ng or placebo, GSK2245035 - 40 ng or placebo, GSK2245035 - 80 ng or placebo |
| PlaceboAs for GSK2245035 nasal spray solution except for omission of the active ingredient | Other | GSK2245035 - 120 ng or placebo, GSK2245035 - 160 ng or placebo, GSK2245035 - 40 ng or placebo, GSK2245035 - 80 ng or placebo |
Primary outcome
Number of participants experiencing adverse events (AEs)
Time frame: Up to 122 Days
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Hematology parameters as a safety measure
Time frame: Up to 112 Days
The hematology parameters included are platelet count, red blood cell (RBC) count, white blood cell (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils.
Clinical Chemistry parameters as a safety measure
Time frame: Up to 112 Days
Clinical chemistry parameters included are blood urea nitrogen (BUN), creatinine, glucose, potassium, C-Reactive protein (CRP) potassium, chloride, total carbon dioxide, calcium, total and direct bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), alkaline phosphatase, uric acid, protein and albumin
Urinalysis parameters as a safety measure
Time frame: Up to 112 Days
Urinalysis parameters included are specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick, microscopic examination (if blood or protein is abnormal)
Body temperature
Time frame: Up to 112 Days
Systolic and diastolic blood pressure (BP)
Time frame: Up to 112 Days
Pulse rate
Time frame: Up to 112 Days
ECG parameters
Time frame: Up to 112 Days
A 12 lead electrocardiogram (ECG) will be measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Nasal examination
Time frame: Up to 112 Days
Visual nasal examination will be conducted by a trained physician
Nasal symptoms assessment
Time frame: Up to 23 Days
Nasal tolerability symptoms itching, discomfort, post-nasal drip, rhinorrhoea, obstruction will be assessed using a Visual analogue score system
10 secondary outcomes
FEV1 assessment
Time frame: Up to 112 Days
TLR7-induced blood PD biomarkers, including TLR7-induced cytokines
Time frame: Up to 23 Days
TLR7-induced nasal PD biomarkers, including but not limited to induced protein (IP)-10, i.n. nasal lavage fluid
Time frame: Up to 23 Days
Daily rhinitis symptoms and use of medication diaries during the study period
Time frame: Up to 122 Days
Daily asthma symptoms and use of medication diaries during the study period
Time frame: Up to 122 Days
Daily morning peak expiratory flow (PEF) during the study period
Time frame: Up to 112 Days
Exhaled NO assessment
Time frame: Up to 23 Days
Cell counts and differential in nasal lavage
Time frame: Up to 23 Days
Exploratory allergic biomarkers including but not limited to immunoglobulins and cytokines in blood and nasal lavage fluid and tissue
Time frame: Up to 23 Days
Plasma GSK2245035 concentrations
Time frame: Up to 23 Days
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 30 Jan 2017.
- Derived from this study: PubMed 26044169Tsitoura D, Ambery C, Price M, Powley W, Garthside S, Biggadike K, Quint D. Early clinical evaluation of the intranasal TLR7 agonist GSK2245035: Use of translational biomarkers to guide dosing and confirm target engagement. Clin Pharmacol Ther. 2015 Oct;98(4):369-80. doi: 10.1002/cpt.157.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 2 study testing GSK2245035 and Type 1 amber glass bottle in people with Asthma and Rhinitis, 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 8 inclusion and 21 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 30 Jan 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of participants experiencing adverse events (AEs) (time frame: Up to 122 Days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607372, which also lists 1 linked publication.
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 30 Jan 2017.