AsthmaPhase 3NCT01435902
A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
A Phase 3 study testing Fluticasone Furoate/Vilanterol Inhalation Powder and Fluticasone Propionate Inhalation Powder in people with Asthma, run by GlaxoSmithKline.
Trial summary
The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with fluticasone propionate 250 mcg twice daily in adolescent and… Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Furoate/Vilanterol Inhalation Powder and Fluticasone Propionate Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2012
- Phase
- Phase 3
- 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 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Outpatient male or female 12 to 50 years of age
- Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
- Diagnosis of persistent asthma for at least 6 months
- Best pre-bronchodilator FEV1 of at least 70%.
- Current use of a low- to moderate-dose inhaled corticosteroid
- Ability to withhold albuterol 6 hours prior to visits.
- Physically able to perform exercise testing on a treadmill when albuterol has been withheld
Who cannot join
- Intermittent asthma, seasonal asthma, or exercise-induced asthma only
- Symptomatic allergic rhinitis and/or thrush
- Abnormal, clinically significant electrocardigraph
- Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
- Asthma exacerbation within 12 weeks of first visit
- Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
Show all 12Show fewer
- Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
- Allergy to study drugs or study drug excipients
- Concomitant medications that could interact with study medications or affect the course of asthma
- Tobacco use within last year and/or a 10 pack-years history
- Inability to comply with requirements of the study
- Affiliation with investigator's site (example: family member)
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Crossover Comparison of Fluticasone Furoate/Vilanterol 100/25 mcg Once Daily Versus Fluticasone Propionate 250 mcg Twice Daily in Asthmatic Adolescent and Adult Subjects With Exercise-Induced Bronchoconstriction
The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with fluticasone propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with persistent asthma.
- Conditions
- Asthma
- Being tested
- Fluticasone Furoate/Vilanterol Inhalation Powder, Fluticasone Propionate Inhalation Powder
- Keywords
- exercise-induced bronchospasm, Activity/Exercise induced bronchospasm, asthma
- Medical subject headings
- Asthma, Asthma, Exercise-Induced, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate/Vilanterol Inhalation PowderDrug
Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks
Fluticasone Propionate Inhalation PowderDrug
Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Furoate/Vilanterol | Active comparator | Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks Receives: Drug: Fluticasone Furoate/Vilanterol Inhalation Powder |
| Fluticasone Propionate | Active comparator | Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks Receives: Drug: Fluticasone Propionate Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose
Measured: At the end of treatment Week 4
Secondary outcomes (5)
Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose
Measured: At the end of treatment Week 4
Time required for recovery to within 5% of the pre-exercise baseline FEV1 from the time of the maximal percentage decrease from baseline following the challenge at 1 hour, 12 hours, and 23 hours post-dose
Measured: At the end of treatment Week 4
AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose
Measured: At the end of treatment Week 4
Evaluation of a categorical treatment response using the percentage of subjects who demonstrate a decrease from the pre-exercise baseline in FEV1 of 1) <10%, 2) 10 to <20%, and 3) =/>20%.
Measured: At the end of treatment Week 4
Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose.
Measured: At the end of treatment Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Study was cancelled prior to enrolling any subjects
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT01435902
- Sponsor's protocol ID
- 106847
- Status last verified
- Jun 2014
- First submitted
- 15 Sep 2011
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Crossover Comparison of Fluticasone Furoate/Vilanterol 100/25 mcg Once Daily Versus Fluticasone Propionate 250 mcg Twice Daily in Asthmatic Adolescent and Adult Subjects With Exercise-Induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT01435902
- Acronym / sponsor ID
- 106847
- Conditions
- Asthma
- Keywords
- exercise-induced bronchospasm, Activity/Exercise induced bronchospasm, asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled prior to enrolling any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 19 Sep 2011 (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.
The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with fluticasone propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Furoate/Vilanterol | Active comparator | Drug: Fluticasone Furoate/Vilanterol Inhalation PowderFluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks |
| Fluticasone Propionate | Active comparator | Drug: Fluticasone Propionate Inhalation PowderFluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Outpatient male or female 12 to 50 years of age
- Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
- Diagnosis of persistent asthma for at least 6 months
- Best pre-bronchodilator FEV1 of at least 70%.
- Current use of a low- to moderate-dose inhaled corticosteroid
Key exclusion criteria (12 listed)
- Intermittent asthma, seasonal asthma, or exercise-induced asthma only
- Symptomatic allergic rhinitis and/or thrush
- Abnormal, clinically significant electrocardigraph
- Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
- Asthma exacerbation within 12 weeks of first visit
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 |
|---|---|---|
| Fluticasone Furoate/Vilanterol Inhalation PowderFluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks | Drug | Fluticasone Furoate/Vilanterol |
| Fluticasone Propionate Inhalation PowderFluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks | Drug | Fluticasone Propionate |
Primary outcome
Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose
Time frame: At the end of treatment Week 4
5 secondary outcomes
Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose
Time frame: At the end of treatment Week 4
Time required for recovery to within 5% of the pre-exercise baseline FEV1 from the time of the maximal percentage decrease from baseline following the challenge at 1 hour, 12 hours, and 23 hours post-dose
Time frame: At the end of treatment Week 4
AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose
Time frame: At the end of treatment Week 4
Evaluation of a categorical treatment response using the percentage of subjects who demonstrate a decrease from the pre-exercise baseline in FEV1 of 1) <10%, 2) 10 to <20%, and 3) =/>20%.
Time frame: At the end of treatment Week 4
Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose.
Time frame: At the end of treatment Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone Furoate/Vilanterol Inhalation Powder and Fluticasone Propionate Inhalation Powder in people with Asthma, run by GlaxoSmithKline.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose (time frame: At the end of treatment Week 4). 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 23 Jun 2014.