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AsthmaPhase 2NCT00748306

Study in Mild Asthmatic Patients

A Phase 2 study testing GSK2190915 - 100mcg in people with Asthma, run by GlaxoSmithKline at 4 sites in 2 countries.

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

The purpose of this study is to determine the safety and usefulness of GSK2190915 in asthmatic patients who develop asthma symptoms following being challenged. 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 - 100mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
4 sitesin 2 countries
Study dates
Dec 2008to Sep 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

  • Males and females aged 18 to 55 years inclusive.
  • 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 oophorectomy 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 Section 8.1. This criterion must be followed from the time of the first dose of study medication until 5 terminal half-live 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.
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  • Sensitivity to methacholine with a provocative concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of <8 mg/mL at screening
  • Subjects who are able to produce acceptable induced sputum samples (as defined in the Study procedures Manual).
  • 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.
  • [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.
  • Screening allergen challenge demonstrates that the subject experiences both an early and late 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. The late asthmatic response must include a fall in FEV1 of ≥ 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen.
  • 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

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • 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 (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
  • 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 hypercapnia, respiratory arrest and/or hypoxic seizures.
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  • Symptomatic with hay fever at screening or predicted to have symptomatic hayfever during the time of study.
  • 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 as described in the restrictions section.
  • 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 methacholine and/or 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, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United Kingdom3 sites

  • GSK Investigational Site

    London, NW10 7EW

  • GSK Investigational Site

    London, W1G 8HU

  • GSK Investigational Site

    Manchester, Lancashire, M23 9LT

Other trials in United Kingdom

Netherlands1 site

  • GSK Investigational Site

    Leiden, 2333 CL

Other trials in Netherlands

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, 2-period Cross-over Study to Evaluate the Effect of Treatment With GSK2190915 on the Allergen-induced Asthmatic Response in Subjects With Mild Asthma

The purpose of this study is to determine the safety and usefulness of GSK2190915 in asthmatic patients who develop asthma symptoms following being challenged.

Conditions
Asthma
Being tested
GSK2190915 - 100mcg, Placebo
Keywords
challenge, early asthmatic response, mild asthmatics, Allergen, methacholine
Medical subject headings
Asthma

What participants receive

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

  • GSK2190915 - 100mcgDrug

    Also called GSK2190915

    GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor

  • PlaceboDrug

    Matching Intervention Drug

Study groups in NCT00748306
Study groupRoleWhat they receive
GSK2190915ExperimentalIntervention
Receives: Drug: GSK2190915 - 100mcg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in FEV1% from 0-2 hrs

    Measured: 0-2 hours

Secondary outcomes (9)

  1. Late Asthmatic Response (LAR): minimum FEV1 and weighted mean FEV1 between 4-10 hours after allergen challenge on Day 3 of each treatment period.

    Measured: 4 - 10 hours after allergen challenge

  2. Incidence of treatment emergent adverse events.

    Measured: Duration of Study

  3. Vital signs, ECG, FEV1, Biomarkers(LTE4, LTB4 and IgE) and safety laboratory parameters.

    Measured: Duration of Study

  4. Assessment of FEV1 post-dose on Days 1, 3, (post-dose on Days 3 prior to allergen challenge) and Day 6 of each treatment period.

    Measured: upto Day 3

  5. Concentration of exhaled nitric oxide post-dose on Day 3, 4 and 6 of each treatment period.

    Measured: Day 3 - 6

  6. Provocative concentration of methacholine resulting in a 20% reduction in FEV1 (PC20) on Day 4 of each treatment period.

    Measured: Day 4

  7. Biomarkers (LTE4, LTB4 and IgE) of inflammation in blood, urine and sputum of each treatment period.

  8. Assessment of established markers of anti-inflammatory activity in sputum on Day 4 and Day 6.

    Measured: Day 4

  9. Derived appropriate PK parameters for GSK2190915.

    Measured: Duration of Study

Timeline

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

  1. First posted8 Sep 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00748306
Sponsor's protocol ID
111834
Status last verified
Oct 2016
First submitted
5 Sep 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.

Publications

  • Kent SE, Boyce M, Diamant Z, Singh D, O'Connor BJ, Saggu PS, Norris V. The 5-lipoxygenase-activating protein inhibitor, GSK2190915, attenuates the early and late responses to inhaled allergen in mild asthma. Clin Exp Allergy. 2013 Feb;43(2):177-86. doi: 10.1111/cea.12002.

    PubMed 23331559

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK2190915 - 100mcg in people with Asthma, run by GlaxoSmithKline at 4 sites in 2 countries.

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 14 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 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 4 sites in United Kingdom, Netherlands. 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?

Change in FEV1% from 0-2 hrs (time frame: 0-2 hours). 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 NCT00748306, 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 12 Oct 2016.

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Study in Mild Asthmatic Patients (NCT00748306) | AzTrials