Mild Asthma and Allergic RhinitisPhase 2NCT01788813

To Investigate the Safety, Pharmacodynamics and Effect on Allergic Reactivity of the Toll-like Receptor 7 (TLR7) Agonist GSK2245035 in Subjects With Respiratory Allergies

A Phase 2 study testing GSK2245035 in people with Mild Asthma and Allergic Rhinitis, run by GlaxoSmithKline at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Mild Asthma and Allergic Rhinitis
What is being tested?: GSK2245035
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteCanada
Study dates: Mar 2013to Aug 2014
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 65 years
All sexes
No healthy volunteers
Adult, Older 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
Body weight >=45 kilograms (kg)
History of symptomatic pollen- or perennial allergen- driven allergic rhinitis with or without mild asthma (with a clear link between exposure to allergen and development of symptoms) for more than 2 years
Positive skin allergy test (wheal >=3 mm[millimeters]) or serum allergen-specific Immunoglobulin E (IgE) (>=class 2) for perennial allergens and/or pollen allergens, relevant to the area of the research unit, within a year from the study start
Positive screening nasal allergen challenge, defined by a Total nasal symptoms score (TNSS) response of >=5 (on a 12 point scale) and a decrease in Peak Nasal Inspiratory Flow (PNIF) of >30%
Males and non-pregnant or non-lactating females between 18 and 65 years of age inclusive at the time of signing the consent form

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A female subject is eligible to participate if she is 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) >40 million international units (MIU)/mL and estradiol <40 picogram (pg)/mL (<147 picomoles (pmol)/liter (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 with a failure rate of <1% 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
A female subject is eligible to participate if she is of child-bearing potential and has a negative early pregnancy test at screening, confirmed menses and/or a negative early pregnancy test within 10 days prior to the first dosing visit, a negative early pregnancy test before each dosing and agrees: to use one of the required contraception methods with a failure rate of <1% starting at least 2 weeks prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. The subject must agree to use contraception until four days after the last dosing; or has only same-sex partners, when this is her preferred and usual lifestyle
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods: Condom plus partner use of a required highly effective contraceptive (with a failure rate of <1%); or Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. This criterion must be followed from the time of the first dose of study medication until four days after the last dosing

Who cannot join

CRITERIA BASED UPON MEDICAL HISTORIES
History of immunological disorders or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, hematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator and GlaxoSmithKline (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
History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 drinks for males or >12 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits
History of drug or other allergy that, in the opinion of the investigator or GSK medical monitor, contraindicates participation in this study

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Serious asthma exacerbation requiring hospital visit and/ or treatment with oral steroids or high doses of inhaled steroids within 6 weeks prior to screening
Subjects with a history of treatment with allergen-specific immunotherapy within the past 5 years are excluded. (Subjects who received incomplete treatment with allergen-specific immunotherapy more than 5 years ago may be included at the discretion of the investigator and GSK Medical Monitor)
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to first dosing and throughout the treatment and follow-up period unless in the opinion of the investigator and/or GSK medical monitor the medication will not interfere with the study procedures or compromise subject safety. Acetaminophen is an exception and will be permitted at daily doses of up to 2 g from screening to follow-up. Approved contraceptives and pre-approved medications as specified in the protocol are also exempt
Subjects using steroid treatment for allergic rhinitis and/or asthma may participate in the study if they can remain free of medication throughout the treatment and follow-up period starting from the following periods of time prior to screening: 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 long-acting inhaled beta-agonists from 1 week prior to screening and throughout the treatment and follow-up period; Nasal antihistamines-48 hours prior each visit; Oral antihistamines-76 hours prior each visit; Nasal decongestants-24 hours prior each visit; Oral decongestants-24 hours prior each visit; Short acting inhaled beta-agonists-48 hours prior each visit
CRITERIA BASED UPON DIAGNOSTIC ASSESSMENTS
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive test for Human Immunodeficiency Virus (HIV) antibody
A positive screening or pre-dose drug/alcohol screen, with the following exceptions: (a) Subjects with positive results at the initial drug screening are excluded unless they have previously disclosed the use of a prescription drug that could cause a positive drug screen that according to the opinion of the Investigator and GSK Medical Monitor will not pose any safety risks to the subject and will not compromise the study (b) Subjects with a positive marijuana (THC) screen may be entered into the study at the investigator's discretion but all pre-dose drug screens must be negative (c) Subjects with a positive alcohol screen may have this test repeated at a subsequent screening visit but all pre-dose alcohol screens must be negative.
Pre-bronchodilator FEV1 <=70% of predicted at screening
OTHER CRITERIA
Participation in a clinical trial with receipt of an investigational product within 3 months prior to the first dosing day. Subjects may only participate in this study once even though the study is being conducted in two separate allergy seasons
Exposure to more than four new chemical entities within 3 months prior to the first dosing day
Donation of blood or blood products in excess of 500 mL within a 56-day period
Subject is mentally or legally incapacitated
Unwillingness or inability to follow the procedures outlined in the protocol

Trial locations and contacts

1 site in 1 country.

Canada1 site

GSK Investigational Site
Kingston, Ontario, K7L 2V7

Other trials in Canada

About this study

Official title: A Randomized, Double Blind, Placebo-controlled Study to Investigate the Safety, Pharmacodynamics and Effect on Allergic Reactivity of Repeat Intranasal Administration of the TLR7 Agonist GSK2245035 in Subjects With Respiratory Allergies

The purpose of this study is to examine the safety and effects on the immune system of treatment with GSK2245035 in subjects who suffer from nasal symptoms caused by an allergy to pollen or perennial allergen, with or without mild asthma. In addition, the effect of treatment with GSK2245035 on the body's allergic response in test situations will be explored. Approximately 28 subjects will receive GSK2245035 (up to 14 subjects each receiving 80 nanograms [ng] GSK2245035 and up to 14 subjects each receiving 20 ng GSK2245035) and 14 subjects will receive the dummy drug (placebo) during the study. Assignment of a subject to GSK2245035 or placebo will be done by chance, like flipping a coin. Neither the subjects nor the clinic staff will know whether a subject is being dosed with GSK2245035 or placebo during the course of the study. The study will include (a) Screening phase where the eligibility of subjects for enrolment will be assessed (b) Treatment phase during which subjects will receive either 8 nasal sprays of GSK2245035 80 ng or a matching placebo once weekly for 8 weeks (each dose will be split between the two nostrils). Subjects participating in this study in 2014 will receive a reduced dose of 20 ng i.n. of GSK2245035 once weekly for eight administrations (c) Follow-up period where any GSK2245035 induced changes to the immune system and the effect of treatment on the body's allergic response in test situations will be monitored. The maximum planned study duration for all subjects, including the screening, treatment and follow-up periods, is approximately 180 days.

Conditions: Mild Asthma and Allergic Rhinitis
Being tested: GSK2245035, Placebo
Keywords: Repeat Dose Safety, Allergic Asthma, Effect on Allergen Reactivity, Allergic Rhinitis, TLR7 Agonist, Pharmacodynamics
Medical subject headings: Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2245035Drug
Nasal spray solution, to be given intranasal, 80 ng/20 ng once weekly for 8 weeks
PlaceboDrug
Nasal Spray Solution, to be given intranasal, once weekly for 8 weeks

Study groups in NCT01788813
Study group	Role	What they receive
GSK2245035 Arm	Experimental	Subjects participating prior to 2014 will receive i.n GSK2245035 80 ng once weekly for 8 weeks (each dose will be split between the two nostrils). Subjects participating in 2014 will receive i.n GSK2245035 20 ng once weekly for 8 weeks (each dose will be split between the two nostrils). Receives: Drug: GSK2245035
Placebo Arm	Placebo comparator	Subjects will receive i.n placebo once weekly for 8 weeks (each dose will be split between the two nostrils) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety assessed by number of subjects with adverse events
Measured: Up to 180 days
Safety assessed by measurement of body temperature
The measurement of body temperature with an automatic thermometer placed in the subject's mouth will be performed by the research unit staff when a subject is in the unit and by the individual when a subject is not in the unit
Measured: Up to 180 days
Safety assessed by lung function measurements
Spirometry will be performed at screening and Peak Expiratory Flow will be measured at all other planned time points
Measured: Up to 180 days
Safety assessed by measurement of clinical laboratory parameters
Hematology, clinical chemistry, urinalysis and additional parameters to be tested
Measured: Up to 180 days
Nasal examination for assessment of nasal tolerability
Visual examination of the nose will be done to assess the color of mucosa, degree of turbinate swelling, presence/description of any secretion, presence/absence of infection, post-nasal drip, crusting, signs of bleeding and any other signs of irritancy
Measured: Up to 180 days
Nasal symptoms monitoring for assessment of nasal tolerability
Nasal tolerability will be assessed using a Visual analogue scale scoring system. Subjects will be asked to respond to various statements of a questionnaire by placing a small vertical mark on a horizontal line, 10 centimeters in length, with a statement placed at each end of the line. Nasal symptoms of rhinorrhea, blockage, itchiness, soreness or dryness and modification of the sense of taste/smell will be assessed
Measured: Up to 7 weeks (Dosing Visits 1 to 8)
Measurement of TLR7-induced blood Pharmacodynamic (PD) biomarkers, including TLR7-induced cytokines
Blood samples will be collected to measure levels of TLR7-induced soluble biomarkers and/or allergic blood biomarkers, including but not limited to immunoglobulins
Measured: Up to 180 days (Screening Allergen Challenge Visit 2, Dosing Visits 1 and 8, Follow-up Allergen Challenge Visits
Measurement of TLR7-induced nasal PD biomarkers, including but not limited to Interferon gamma-induced protein 10 (IP-10) measurement in nasal fluid
During allergen challenge visits, nasal lavage samples will be collected from one nostril only; nasal filters will be inserted in the other nostril and will remain there for 5 minutes
Measured: Up to 180 days (Screening Allergen Challenge Visit 2, Dosing Visits 1 and 8, Follow-up Allergen Challenge Visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Aug 2014

First posted11 Feb 2013 (estimated)
Study startMar 2013
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mild Asthma and Allergic 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01788813
Sponsor's protocol ID: 116958
Status last verified: Aug 2014
First submitted: 7 Feb 2013
Last updated: 20 Oct 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Asthma and Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2014. 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, Pharmacodynamics and Effect on Allergic Reactivity of Repeat Intranasal Administration of the TLR7 Agonist GSK2245035 in Subjects With Respiratory Allergies
ClinicalTrials.gov ID: NCT01788813
Acronym / sponsor ID: 116958
Conditions: Mild Asthma and Allergic Rhinitis
Keywords: Repeat Dose Safety, Allergic Asthma, Effect on Allergen Reactivity, Allergic Rhinitis, TLR7 Agonist, Pharmacodynamics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 11 Feb 2013 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
GSK2245035 Arm	Experimental	Drug: GSK2245035Subjects participating prior to 2014 will receive i.n GSK2245035 80 ng once weekly for 8 weeks (each dose will be split between the two nostrils). Subjects participating in 2014 will receive i.n GSK2245035 20 ng once weekly for 8 weeks (each dose will be split between the two nostrils).
Placebo Arm	Placebo comparator	Drug: PlaceboSubjects will receive i.n placebo once weekly for 8 weeks (each dose will be split between the two nostrils)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 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
Body weight >=45 kilograms (kg)
History of symptomatic pollen- or perennial allergen- driven allergic rhinitis with or without mild asthma (with a clear link between exposure to allergen and development of symptoms) for more than 2 years
Positive skin allergy test (wheal >=3 mm[millimeters]) or serum allergen-specific Immunoglobulin E (IgE) (>=class 2) for perennial allergens and/or pollen allergens, relevant to the area of the research unit, within a year from the study start
Positive screening nasal allergen challenge, defined by a Total nasal symptoms score (TNSS) response of >=5 (on a 12 point scale) and a decrease in Peak Nasal Inspiratory Flow (PNIF) of >30%

Key exclusion criteria (22 listed)

CRITERIA BASED UPON MEDICAL HISTORIES
History of immunological disorders or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, hematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator and GlaxoSmithKline (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
History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 drinks for males or >12 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits

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
GSK2245035Nasal spray solution, to be given intranasal, 80 ng/20 ng once weekly for 8 weeks	Drug	GSK2245035 Arm
PlaceboNasal Spray Solution, to be given intranasal, once weekly for 8 weeks	Drug	Placebo Arm

Primary outcome

Safety assessed by number of subjects with adverse events
Time frame: Up to 180 days
Safety assessed by measurement of body temperature
Time frame: Up to 180 days
The measurement of body temperature with an automatic thermometer placed in the subject's mouth will be performed by the research unit staff when a subject is in the unit and by the individual when a subject is not in the unit
Safety assessed by lung function measurements
Time frame: Up to 180 days
Spirometry will be performed at screening and Peak Expiratory Flow will be measured at all other planned time points
Safety assessed by measurement of clinical laboratory parameters
Time frame: Up to 180 days
Hematology, clinical chemistry, urinalysis and additional parameters to be tested
Nasal examination for assessment of nasal tolerability
Time frame: Up to 180 days
Visual examination of the nose will be done to assess the color of mucosa, degree of turbinate swelling, presence/description of any secretion, presence/absence of infection, post-nasal drip, crusting, signs of bleeding and any other signs of irritancy
Nasal symptoms monitoring for assessment of nasal tolerability
Time frame: Up to 7 weeks (Dosing Visits 1 to 8)
Nasal tolerability will be assessed using a Visual analogue scale scoring system. Subjects will be asked to respond to various statements of a questionnaire by placing a small vertical mark on a horizontal line, 10 centimeters in length, with a statement placed at each end of the line. Nasal symptoms of rhinorrhea, blockage, itchiness, soreness or dryness and modification of the sense of taste/smell will be assessed
Measurement of TLR7-induced blood Pharmacodynamic (PD) biomarkers, including TLR7-induced cytokines
Time frame: Up to 180 days (Screening Allergen Challenge Visit 2, Dosing Visits 1 and 8, Follow-up Allergen Challenge Visits
Blood samples will be collected to measure levels of TLR7-induced soluble biomarkers and/or allergic blood biomarkers, including but not limited to immunoglobulins
Measurement of TLR7-induced nasal PD biomarkers, including but not limited to Interferon gamma-induced protein 10 (IP-10) measurement in nasal fluid
Time frame: Up to 180 days (Screening Allergen Challenge Visit 2, Dosing Visits 1 and 8, Follow-up Allergen Challenge Visits
During allergen challenge visits, nasal lavage samples will be collected from one nostril only; nasal filters will be inserted in the other nostril and will remain there for 5 minutes

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 20 Oct 2014.

Related trials for Mild Asthma and Allergic Rhinitis

RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
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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 in people with Mild Asthma and Allergic 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 9 inclusion and 22 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 20 Oct 2014. 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 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?

Safety assessed by number of subjects with adverse events (time frame: Up to 180 days). The study lists 8 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 NCT01788813.

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 20 Oct 2014.