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AsthmaPhase 2NCT01248975

Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma

A Phase 2 study testing FP/SAL 250/50mcg BID, GSK2190915 200mg QD (AM) and GSK2190915 100mg QD (AM) in people with Asthma, run by GlaxoSmithKline at 19 sites in 3 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 primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Asthma
What is being tested?
FP/SAL 250/50mcg BID, GSK2190915 200mg QD (AM) and GSK2190915 100mg QD (AM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
145 participants
Where
19 sitesin 3 countries
Study dates
Dec 2010to Oct 2011
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 years of age or older
  • Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
  • Asthma diagnosis as defined by the National Institutes of Health
  • Best FEV1 of 50% to <80% of the predicted normal value
  • For current and former smokers, a post-albuterol FEV1/FVC ratio of >0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
  • ≥ 12% and ≥200mL reversibility of FEV1
Show all 10Show fewer
  • Must have been using FP/SAL 250/50mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
  • Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
  • Must be able and willing to give written informed consent to take part in the study.
  • Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.

Who cannot join

  • History of life-threatening asthma
  • Recent asthma exacerbation
  • Concurrent respiratory disease
  • Recent respiratory infection
  • Liver disease
  • Other concurrent diseases/abnormalities
Show all 17Show fewer
  • Oral candidiasis
  • Drug allergy
  • Milk protein allergy
  • Immunosuppressive Medications
  • Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
  • OATP1B1 substrates within 4 weeks of Visit 1
  • Cytochrome P450 3A4 (CYP 3A4) Inhibitors
  • Cytochrome P450 3A4 (CYP 3A4) Inducers
  • Investigational Medications
  • Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol
  • Affiliation with Investigator's Site

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

Ukraine13 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49027

  • GSK Investigational Site

    Dnipropetrovsk, 49051

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Ivano-Frankivsk, 76018

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kharkiv, 61037

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kiev, 3680

  • GSK Investigational Site

    Kyiv, 02091

  • GSK Investigational Site

    Kyiv, 02232

  • GSK Investigational Site

    Kyiv, 03115

  • GSK Investigational Site

    Kyiv, 04107

  • GSK Investigational Site

    Zaporizhia, 69035

Other trials in Ukraine

Bulgaria3 sites

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Poland3 sites

  • GSK Investigational Site

    Bialystok, 15-084

  • GSK Investigational Site

    Lodz, 93-329

  • GSK Investigational Site

    Tarnów, 33-100

Other trials in Poland

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 300mg as Compared to Adding Montelukast 10mg or Placebo Tablets QD to Fluticasone Propionate/Salmeterol 250/50mcg Diskus BID

The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.

The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.

Conditions
Asthma
Being tested
FP/SAL 250/50mcg BID, GSK2190915 200mg QD (AM), GSK2190915 100mg QD (AM), Montelukast 10mg QD (PM), Placebo tablets (2) (AM)
Keywords
asthma, GSK2190915
Medical subject headings
Asthma

What participants receive

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

  • FP/SAL 250/50mcg BIDDrug

    FP/SAL 250/50mcg BID

  • GSK2190915 200mg QD (AM)Drug

    GSK2190915 200mg QD (AM)

  • GSK2190915 100mg QD (AM)Drug

    GSK2190915 100mg QD (AM)

  • Montelukast 10mg QD (PM)Drug

    Montelukast 10mg QD (PM)

  • Placebo tablets (2) (AM)Drug

    Placebo tablets (2) (AM)

  • Placebo capsule (PM)Drug

    Placebo capsule (PM)

Study groups in NCT01248975
Study groupRoleWhat they receive
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)ExperimentalFP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
Receives: Drug: FP/SAL 250/50mcg BID; Drug: GSK2190915 200mg QD (AM); Drug: GSK2190915 100mg QD (AM); Drug: Placebo capsule (PM)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)Active comparatorFP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
Receives: Drug: FP/SAL 250/50mcg BID; Drug: Montelukast 10mg QD (PM); Drug: Placebo tablets (2) (AM)
FP/SAL 250/50mcg BID plus placebo BIDPlacebo comparatorP/SAL 250/50mcg BID plus placebo BID
Receives: Drug: FP/SAL 250/50mcg BID; Drug: Placebo tablets (2) (AM); Drug: Placebo capsule (PM)

What is being measured

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

  1. Trough (AM pre-dose and pre-rescue bronchodilator) FEV1

    Measured: at the end of the 6 week treatment period.

Secondary outcomes (11)

  1. • Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF

    Measured: averaged over the last 3 weeks of the 6 week treatment period.

  2. • Daily PM PEF

    Measured: averaged over the last 3 weeks of the 6 week treatment period.

  3. • Daily (average of AM and PM)

    Measured: averaged over the last 3 weeks of the 6 week treatment period

  4. • Daily asthma symptom score

    Measured: averaged over the last 3 weeks of the 6 week treatment period.

  5. • Daily rescue salbutamol use

    Measured: averaged over the last 3 weeks of the 6 week treatment period.

  6. • Percentage of symptom-free days

    Measured: during the last 3 weeks of the 6 week treatment period.

  7. • Percentage of symptom-free nights

    Measured: during the last 3 weeks of the 6 week treatment period.

  8. • Percentage of rescue-free days

    Measured: during the last 3 weeks of the 6 week treatment period.

  9. • Percentage of rescue-free nights

    Measured: during the last 3 weeks of the 6 week treatment period.

  10. • Percentage of nights without awakenings due to asthma

    Measured: during the last 3 weeks of the 6 week treatment period.

  11. • Proportion of subjects withdrawn due to lack of efficacy

    Measured: during the last 3 weeks of the 6 week treatment period.

Timeline

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

  1. First posted25 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

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
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01248975
Sponsor's protocol ID
114387
Status last verified
Nov 2016
First submitted
24 Nov 2010
Last updated
25 Nov 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

  • Snowise NG, Clements D, Ho SY, Follows RM. Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma. Curr Med Res Opin. 2013 Dec;29(12):1663-74. doi: 10.1185/03007995.2013.842163. Epub 2013 Sep 19.

    PubMed 24010736

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FP/SAL 250/50mcg BID, GSK2190915 200mg QD (AM) and GSK2190915 100mg QD (AM) in people with Asthma, run by GlaxoSmithKline at 19 sites in 3 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 10 inclusion and 17 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 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Ukraine, Bulgaria, Poland. 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?

Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 (time frame: at the end of the 6 week treatment period.). 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 NCT01248975, 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 25 Nov 2016.

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