AsthmaPhase 2NCT01128569

Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response

A Phase 2 study testing Fluticasone Furoate and FF/Vilanterol (VI; GW642444M) in people with Asthma, run by GlaxoSmithKline at 4 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

We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: Fluticasone Furoate and FF/Vilanterol (VI; GW642444M)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 4 sitesin 3 countries
Study dates: Jan 2010to Oct 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
Females of non-child bearing potential.
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
Methacholine challenge PC20 < 8 mg/mL at screening
Screening allergen challenge demonstrates that the subject experiences an early asthmatic response

Who cannot join

Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Subject is hypertensive at screening
Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
History of life-threatening asthma
Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
Unable to abstain from short acting beta agonists

Show all 10Show fewer

Unable to abstain from antihistamines
Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
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
undergoing allergen desensitisation therapy

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

United Kingdom2 sites

GSK Investigational Site
London, NW10 7EW
GSK Investigational Site
Manchester, M23 9QZ

Other trials in United Kingdom

Germany1 site

GSK Investigational Site
Berlin, State of Berlin, 14050

Other trials in Germany

New Zealand1 site

GSK Investigational Site
Wellington, 6021

Other trials in New Zealand

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Three-way Crossover, Repeat Dose Pilot Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination and Fluticasone Furoate on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma

Conditions: Asthma
Being tested: Fluticasone Furoate, FF/Vilanterol (VI; GW642444M), Placebo
Keywords: mild asthma, allergen challenge, early asthmatic response
Medical subject headings: Asthma

What participants receive

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

Fluticasone FuroateDrug
Also called FF
FF
FF/Vilanterol (VI; GW642444M)Drug
Also called FF/VI
FF/VI
PlaceboDrug
Placebo Inhaler

Study groups in NCT01128569
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Inhaler Receives: Drug: Placebo
inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)	Active comparator	ICS/LABA inhaler Receives: Drug: FF/Vilanterol (VI; GW642444M)
ICS	Active comparator	ICS inhaler Receives: Drug: Fluticasone Furoate

What is being measured

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

Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.
Measured: Baseline and Day 29 of each treatment period (up to Study Day 197)

Secondary outcomes (3)

Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.
Measured: Baseline and Day 29 of each treatment period (up to Study Day 197)
Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0-2 hour, following the 22-23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value
Measured: Baseline and Day 29 of each treatment period (up to Study Day 197)
Number of Participants With Treatment-emergent Adverse Events (AEs)
The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.
Measured: From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)

Timeline

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

Jan 2010Oct 2010

First posted24 May 2010 (estimated)
Study startJan 2010
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01128569
Sponsor's protocol ID: 113090
Status last verified: Nov 2016
First submitted: 20 May 2010
Last updated: 18 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
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

Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M. Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial. Clin Transl Allergy. 2012 Jun 27;2(1):11. doi: 10.1186/2045-7022-2-11.
PubMed 22738148

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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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Three-way Crossover, Repeat Dose Pilot Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination and Fluticasone Furoate on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma
ClinicalTrials.gov ID: NCT01128569
Acronym / sponsor ID: 113090
Conditions: Asthma
Keywords: mild asthma, allergen challenge, early asthmatic response
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 24 May 2010 (estimated)
Results: Posted 11 Sep 2013

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo Inhaler
inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)	Active comparator	Drug: FF/Vilanterol (VI; GW642444M)ICS/LABA inhaler
ICS	Active comparator	Drug: Fluticasone FuroateICS inhaler

Who may qualify

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

Key inclusion criteria (7 listed)

Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
Females of non-child bearing potential.
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

Key exclusion criteria (10 listed)

Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Subject is hypertensive at screening
Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
History of life-threatening asthma
Symptomatic with hay fever at screening or predicted to have symptomatic hayfever

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 FuroateAlso: FFFF	Drug	ICS
FF/Vilanterol (VI; GW642444M)Also: FF/VIFF/VI	Drug	inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)
PlaceboPlacebo Inhaler	Drug	Placebo

Primary outcome

Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
Time frame: Baseline and Day 29 of each treatment period (up to Study Day 197)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.

3 secondary outcomes

Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
Time frame: Baseline and Day 29 of each treatment period (up to Study Day 197)
Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
Time frame: Baseline and Day 29 of each treatment period (up to Study Day 197)
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)

Results and safety

Results posted to the registry on 11 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg	9	9
Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg	8	8
Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo	9	9
Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg	8	8
Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg	9	9
Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo	9	9

Primary outcome: Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period

Time frame: Baseline and Day 29 of each treatment period (up to Study Day 197). Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 45	FF 100 µg OD n = 49	FF/VI 100/25 µg OD n = 46
Value	-0.372 (0.0557)	-0.210 (0.0549)	-0.227 (0.0550)

Placebo vs FF 100 µg OD: Mean Difference (Final Values): 0.162 (95% CI 0.087 to 0.237)
Placebo vs FF/VI 100/25 µg OD: Mean Difference (Final Values): 0.145 (95% CI 0.069 to 0.222)
FF 100 µg OD vs FF/VI 100/25 µg OD: Mean Difference (Final Values): -0.017 (95% CI -0.091 to 0.057)

Population analysed: Intent-to-Treat (ITT) Population: par. randomized to treatment who received \>=1 dose of study drug. Only those par. available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, par.-level Baseline, period level Baseline, country, sex, and age.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 51 (0%)	15 of 51 (29.4%)	Not reported
FF 100 µg OD	0 of 51 (0%)	18 of 51 (35.3%)	Not reported
FF/VI 100/25 µg OD	0 of 51 (0%)	11 of 51 (21.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22738148Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M. Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial. Clin Transl Allergy. 2012 Jun 27;2(1):11. doi: 10.1186/2045-7022-2-11.
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

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluticasone Furoate and FF/Vilanterol (VI; GW642444M) in people with Asthma, run by GlaxoSmithKline at 4 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 7 inclusion and 10 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 18 Jan 2017. 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, Germany, New Zealand. 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?

Yes. Results are posted in the registry (first posted 11 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period (time frame: Baseline and Day 29 of each treatment period (up to Study Day 197)). 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 NCT01128569, 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 18 Jan 2017.