AsthmaPhase 2NCT00766090

Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma

A Phase 2 study testing GW685698X in people with Asthma, run by GlaxoSmithKline at 16 sites in United States.

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 compare once and twice daily GW685698 in asthma Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: GW685698X
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 190 participants
Where: 16 sitesUnited States
Study dates: Oct 2008to Mar 2009
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical diagnosis of Asthma
Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
FEV1 between 40-85% predicted
Currently on short acting beta2 agonist therapy

Who cannot join

History of life threatening asthma
Respiratory Infection or oropharyngeal candidiasis
Asthma exacerbation
Uncontrolled disease or clinical abnormality
Allergies
Taking another Investigational medications or other prohibited medications

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Boerne, Texas, 78006
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Cocoa, Florida, 32927
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Torrance, California, 90505
GSK Investigational Site
Waco, Texas, 76712

Other trials in United States

About this study

Official title: A Multi-Centre, Randomized, Double Blind Cross-over Study to Assess the Non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma

The purpose of this study is to compare once and twice daily GW685698 in asthma

Conditions: Asthma
Being tested: GW685698X
Medical subject headings: Asthma

What participants receive

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

GW685698XDrug
Inhaled Corticosteroid

Study groups in NCT00766090
Study group	Role	What they receive
GW685698X	Experimental	Not described Receives: Drug: GW685698X

What is being measured

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

Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.
Measured: Day 28 of the relevant treatment period (up to Study Day 112)

Secondary outcomes (6)

Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.
Measured: From the first dose of the study medication up to Week 16/Early Withdrawal
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.
Measured: Day 28 of the relevant treatment period (up to Study Day 112)
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Measured: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Measured: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Measured: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods
Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.
Measured: From the first dose of the study medication up to Week 16/Early Withdrawal

Timeline

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

Oct 2008Mar 2009

First posted3 Oct 2008 (estimated)
Study startOct 2008
Primary completionMar 2009
Study completionMar 2009

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 (2)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: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00766090
Sponsor's protocol ID: 112202
Status last verified: Oct 2016
First submitted: 2 Oct 2008
Last updated: 8 Dec 2016
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

Woodcock A, Bleecker ER, Busse WW, Lotvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011 Dec 21;12(1):160. doi: 10.1186/1465-9921-12-160.
PubMed 22188590
O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
PubMed 27881132

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 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Centre, Randomized, Double Blind Cross-over Study to Assess the Non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma
ClinicalTrials.gov ID: NCT00766090
Acronym / sponsor ID: 112202
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 3 Oct 2008 (estimated)
Results: Posted 7 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare once and twice daily GW685698 in asthma

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
GW685698X	Experimental	Drug: GW685698X

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Clinical diagnosis of Asthma
Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
FEV1 between 40-85% predicted
Currently on short acting beta2 agonist therapy

Key exclusion criteria (6 listed)

History of life threatening asthma
Respiratory Infection or oropharyngeal candidiasis
Asthma exacerbation
Uncontrolled disease or clinical abnormality
Allergies

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
GW685698XInhaled Corticosteroid	Drug	GW685698X

Primary outcome

Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
Time frame: Day 28 of the relevant treatment period (up to Study Day 112)
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.

6 secondary outcomes

Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
Time frame: Day 28 of the relevant treatment period (up to Study Day 112)
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods
Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal

Results and safety

Results posted to the registry on 7 Aug 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 200 µg, FF 100 µg	25	22
Sequence 2: Placebo, FF 100 µg, FF 200 µg	27	27
Sequence 3: FF 100 µg, Placebo, FF 200 µg	23	23
Sequence 4: FF 100 µg, FF 200 µg, Placebo	26	25
Sequence 5: FF 200 µg, Placebo, FF 100 µg	23	23
Sequence 6: FF 200 µg, FF 100 µg, Placebo	23	23
Sequence 7: Placebo, FP 200 µg, FP 100 µg	6	6
Sequence 8: Placebo, FP 100 µg, FP 200 µg	8	8
Sequence 9: FP 100 µg, Placebo, FP 200 µg	7	6
Sequence 10: FP 100 µg, FP 200 µg, Placebo	8	8
Sequence 11: FP 200 µg, Placebo, FP 100 µg	7	7
Sequence 12: FP 200 µg, FP 100 µg, Placebo	7	7

Primary outcome: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period

Time frame: Day 28 of the relevant treatment period (up to Study Day 112). Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 187	FF 200 µg OD n = 140	FF 100 µg BID n = 142	FP 200 µg OD n = 42	FP 100 µg BID n = 43
Value	2.605 (0.0434)	2.714 (0.0444)	2.703 (0.0443)	2.693 (0.0535)	2.737 (0.0533)

Placebo vs FF 200 µg OD: Mean Difference (Final Values): 0.108 (95% CI 0.064 to 0.153), p <0.001, ANCOVA
Placebo vs FF 100 µg BID: Mean Difference (Final Values): 0.098 (95% CI 0.054 to 0.142), p <0.001, ANCOVA
Placebo vs FP 200 µg OD: Mean Difference (Final Values): 0.087 (95% CI 0.014 to 0.161), p = 0.020, ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 187 (0%)	2 of 187 (1.1%)	Not reported
FF 200 µg OD	0 of 140 (0%)	7 of 140 (5%)	Not reported
FF 100 µg BID	0 of 142 (0%)	7 of 142 (4.9%)	Not reported
FP 200 µg OD	0 of 42 (0%)	0 of 42 (0%)	Not reported
FP 100 µg BID	0 of 43 (0%)	0 of 43 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22188590Woodcock A, Bleecker ER, Busse WW, Lotvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011 Dec 21;12(1):160. doi: 10.1186/1465-9921-12-160.
Derived from this study: PubMed 27881132O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
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

16 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 GW685698X in people with Asthma, run by GlaxoSmithKline at 16 sites in United States.

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 4 inclusion and 6 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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?

Yes. Results are posted in the registry (first posted 7 Aug 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?

Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period (time frame: Day 28 of the relevant treatment period (up to Study Day 112)). 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 NCT00766090, which also lists 2 linked publications.

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 8 Dec 2016.