AsthmaPhase 2NCT00812773
Study to Evaluate GSK2190915 in Subjects With Mild Asthma
A Phase 2 study testing GSK2190915 in people with Asthma, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
This study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung function in mild asthmatics using a number of clinical and biological markers of efficacy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- GSK2190915
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2008to Jul 2009
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2)
- Female subjects must be of non childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 40 pg/ml (<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Male subjects 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 5 terminal half-lives post-last dose.
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
- Pre-bronchodilator FEV1 >70% of predicted at screening.
- Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of <= 10 pack years.
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- [number of pack years = (number of cigarettes per day/20) x number of years smoked]
- Demonstration of a positive wheal and flare reaction (>= 3 mm relative to negative control) to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair) on skin prick testing at screening, or within 12 months of study start.
- Methacholine challenge PC20 < 8 mg/mL at screening or previous (in last 6 months) AMP, histamine or methacholine challenge that confirms the diagnosis of asthma
- Screening allergen challenge demonstrates that the subject experiences an early asthmatic response. The early asthmatic response must include a fall in FEV1 of >= 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. Data obtained from screening for LPA111834 may be used for this criteria.
- Signed and dated written informed consent is obtained from the subject
- The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease
- Clinically significant abnormalities in safety laboratory analysis at screening.
- Subject has known history of hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP >150 mmHg or diastolic BP > 90mmHg.
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures
- Symptomatic with hay fever at screening or predicted to have symptomatic hay fever during the time of study
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- Administration of oral or injectable steroids within 5 weeks of screening or intranasal and/or inhaled steroids within 4 weeks of the screening visit.
- Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication, other than short acting inhaled beta-agonists and paracetamol (up to 4 g per day) for the treatment of minor ailments eg headache from 14 days before screening until the follow-up visit.
- Unable to abstain from short acting beta agonists within 8 hours prior to an allergen challenge, dosing with study drug or any lung function assessment.
- If, after 2 concurrent administrations of saline during the allergen challenge at screening the subjects still have a fall in FEV1 of greater than 10%.
- The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months prior to the first dosing day.
- History of being unable to tolerate or complete allergen challenge tests.
- Subject is undergoing allergen desensitisation therapy.
- There is a risk of non-compliance with study procedures.
- History of blood donation (500 mL) within 3 months of starting the clinical study.
- The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (25 ml) of spirits.
- The subject has a screening QTc value of >450msec, PR interval outside the range 120 to 220msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave).
- The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
- The subject has tested positive for HIV antibodies.
- The subject has a positive pre-study urine cotinine/ breath carbon monoxide test or urine drug or urine or breath alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
GSK Investigational Site
London, NW10 7EW
GSK Investigational Site
London, W1G 8HU
GSK Investigational Site
Manchester, M23 9QZ
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of Two Doses of GSK2190915 on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma
This study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung function in mild asthmatics using a number of clinical and biological markers of efficacy.
- Conditions
- Asthma
- Being tested
- GSK2190915
- Keywords
- GSK2190915, Repeat, Oral, Dose, Challenge, Asthma, Allergen
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2190915Drug
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| 3 day repeat dose | Experimental | Not described Receives: Drug: GSK2190915 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Asthmatic Response
Measured: 0-2 hours after allergen challenge on Day 3 of each treatment period.
Secondary outcomes (2)
Lung function as measured by FEV1
Measured: Days 1 and 3
Assess safety and tolerability
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 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
- NCT00812773
- Sponsor's protocol ID
- 112356
- Status last verified
- Oct 2016
- First submitted
- 8 Dec 2008
- Last updated
- 12 Oct 2016
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of Two Doses of GSK2190915 on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma
- ClinicalTrials.gov ID
- NCT00812773
- Acronym / sponsor ID
- 112356
- Conditions
- Asthma
- Keywords
- GSK2190915, Repeat, Oral, Dose, Challenge, Asthma, Allergen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Dec 2008 (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 study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung function in mild asthmatics using a number of clinical and biological markers of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 day repeat dose | Experimental | Drug: GSK2190915 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2)
- Female subjects must be of non childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 40 pg/ml (<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Male subjects 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 5 terminal half-lives post-last dose.
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
- Pre-bronchodilator FEV1 >70% of predicted at screening.
Key exclusion criteria (20 listed)
- Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease
- Clinically significant abnormalities in safety laboratory analysis at screening.
- Subject has known history of hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP >150 mmHg or diastolic BP > 90mmHg.
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures
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 |
|---|---|---|
| GSK2190915Investigational Product | Drug | 3 day repeat dose |
Primary outcome
Early Asthmatic Response
Time frame: 0-2 hours after allergen challenge on Day 3 of each treatment period.
2 secondary outcomes
Lung function as measured by FEV1
Time frame: Days 1 and 3
Assess safety and tolerability
Time frame: Throughout study
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 12 Oct 2016.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2190915 in people with Asthma, run by GlaxoSmithKline at 3 sites in United Kingdom.
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 12 inclusion and 20 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Early Asthmatic Response (time frame: 0-2 hours after allergen challenge on Day 3 of each treatment period.). 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 12 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.