AsthmaPhase 2NCT01499446
A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
A Phase 2 study testing GW685698X (fluticasone furoate) 100mcg Morning, GW685698X (fluticasone furoate) 100mcg Evening and GW685698X (fluticasone furoate) 250mcg Evening in people with Asthma, run by GlaxoSmithKline at 64 sites in 13 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- GW685698X (fluticasone furoate) 100mcg Morning, GW685698X (fluticasone furoate) 100mcg Evening and GW685698X (fluticasone furoate) 250mcg Evening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 669 participants
- Where
- 64 sitesin 13 countries
- Study dates
- Sep 2003to Mar 2004
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatients aged between 16- 65 years.
- Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
- Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1
- Currently receiving inhaled short-acting beta-2 agonists for symptom relief
- A lung function of between 50 to 90% predicted (PEF)
- Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol
Who cannot join
- History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1.
- Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia).
- Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose).
- Undergoing allergen desensitisation therapy.
- Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject's proper completion of the protocol requirements.
- Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit.
Trial locations and contacts
64 sites in 13 countries.
64 sites in 13 countries
Germany19 sites
GSK Investigational Site
Annaberg, Saxony, 09456
GSK Investigational Site
Aue, Saxony, 08280
GSK Investigational Site
Berlin, State of Berlin, 10365
GSK Investigational Site
Berlin, State of Berlin, 10585
GSK Investigational Site
Berlin, State of Berlin, 10717
GSK Investigational Site
Berlin, State of Berlin, 10969
GSK Investigational Site
Berlin, State of Berlin, 13086
GSK Investigational Site
Berlin, State of Berlin, 13597
GSK Investigational Site
Erfurt, Thuringia, 99084
GSK Investigational Site
Eschwege, Hesse, 37269
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Gelnhausen, Hesse, 63571
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33330
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Hanover, Lower Saxony, 30167
GSK Investigational Site
Kassel, Hesse, 34117
GSK Investigational Site
Lüneburg, Lower Saxony, 21335
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, 68723
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
Italy11 sites
GSK Investigational Site
Bussolengo (VR), Veneto, 37012
GSK Investigational Site
Eboli (SA), Campania, 84025
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100
GSK Investigational Site
Florence, Tuscany, 50134
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Pisa, Tuscany, 56124
GSK Investigational Site
Salerno, Campania, 84126
GSK Investigational Site
Sesto San Giovanni (MI), Lombardy, 20099
GSK Investigational Site
Torrette (AN), The Marches, 60126
Russia8 sites
GSK Investigational Site
Kazan', 420015
GSK Investigational Site
Moscow, 115446
GSK Investigational Site
Moscow, 115478
GSK Investigational Site
Moscow, 123 182
GSK Investigational Site
Saint Petersburg, 197 089
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Tomsk, 634 050
GSK Investigational Site
Volgograd, 400130
Bulgaria5 sites
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Sofia, 1431/1000
GSK Investigational Site
Sofia, 1606
GSK Investigational Site
Sofia, 1619
GSK Investigational Site
Varna, 9010
Estonia4 sites
GSK Investigational Site
Kohtal-Jdrve, 31 025
GSK Investigational Site
Pärnu, 80024
GSK Investigational Site
Tallinn, 1162
GSK Investigational Site
Tartu, 51014
Croatia3 sites
GSK Investigational Site
Osijek, 31000
GSK Investigational Site
Split, 21000
GSK Investigational Site
Zagreb, 10000
Greece3 sites
GSK Investigational Site
Athens, 115 28
GSK Investigational Site
Athens, 15669
GSK Investigational Site
Papagos/Athens, 15669
Romania3 sites
GSK Investigational Site
Brasov
GSK Investigational Site
Bucharest, 050159
GSK Investigational Site
Bucharest, 70000
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500551
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500691
Mexico2 sites
GSK Investigational Site
México, 04530
GSK Investigational Site
Mexico City, 06720
South Africa2 sites
GSK Investigational Site
Bloemfontein, 9300
GSK Investigational Site
Cape Town, 7500
Brazil1 site
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 40110-160
About this study
Official title: A Randomised, Double-blind, Double Dummy, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening All Administered by Inhalation Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
- Conditions
- Asthma
- Being tested
- GW685698X (fluticasone furoate) 100mcg Morning, GW685698X (fluticasone furoate) 100mcg Evening, GW685698X (fluticasone furoate) 250mcg Evening, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698X (fluticasone furoate) 100mcg MorningDrug
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X (fluticasone furoate) 100mcg EveningDrug
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X (fluticasone furoate) 250mcg EveningDrug
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
PlaceboDrug
Placebo inhaled twice daily (morning and evening) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| GW685698X (fluticasone furoate) 100mcg Morning | Experimental | Not described Receives: Drug: GW685698X (fluticasone furoate) 100mcg Morning |
| GW685698X (fluticasone furoate) 100mcg Evening | Experimental | Not described Receives: Drug: GW685698X (fluticasone furoate) 100mcg Evening |
| GW685698X (fluticasone furoate) 250mcg Evening | Experimental | Not described Receives: Drug: GW685698X (fluticasone furoate) 250mcg Evening |
| Placebo | Placebo comparator | Not described Receives: Drug: GW685698X (fluticasone furoate) 100mcg Morning; Drug: GW685698X (fluticasone furoate) 100mcg Evening; Drug: GW685698X (fluticasone furoate) 250mcg Evening; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak expiratory flow (PEF)
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.
Measured: 28 days
Secondary outcomes (3)
Peak expiratory flow (PEF)
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 250mcg once daily compared with GW685698X 100mcg once daily both administered in the evening by inhalation via DISKHALER.
Measured: 28 days
PEF
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning, 100mcg once daily in the evening, or GW685698X 250mcg once daily in the evening, compared with placebo
Measured: 28 days
Clinic lung function
Change from baseline in pre bronchodilator clinic lung function (forced expiratory volume in 1 second [FEV1] and PEF) after 28 days of treatment with GW685698X 250mcg once daily in the evening compared with GW685698X 100mcg once daily in the evening
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startSep 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 669 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
- NCT01499446
- Sponsor's protocol ID
- FFA20001
- Status last verified
- Sep 2016
- First submitted
- 8 Dec 2011
- Last updated
- 15 Sep 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
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 27881132Medley H, Orozco S, Allen A. Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma. Clin Ther. 2012 Aug;34(8):1683-95. doi: 10.1016/j.clinthera.2012.06.024. Epub 2012 Jul 13.
PubMed 22796247
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Double Dummy, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening All Administered by Inhalation Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
- ClinicalTrials.gov ID
- NCT01499446
- Acronym / sponsor ID
- FFA20001
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 26 Dec 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 purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GW685698X (fluticasone furoate) 100mcg Morning | Experimental | Drug: GW685698X (fluticasone furoate) 100mcg Morning |
| GW685698X (fluticasone furoate) 100mcg Evening | Experimental | Drug: GW685698X (fluticasone furoate) 100mcg Evening |
| GW685698X (fluticasone furoate) 250mcg Evening | Experimental | Drug: GW685698X (fluticasone furoate) 250mcg Evening |
| Placebo | Placebo comparator | Drug: GW685698X (fluticasone furoate) 100mcg Morning, Drug: GW685698X (fluticasone furoate) 100mcg Evening, Drug: GW685698X (fluticasone furoate) 250mcg Evening, Drug: Placebo |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients aged between 16- 65 years.
- Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
- Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1
- Currently receiving inhaled short-acting beta-2 agonists for symptom relief
- A lung function of between 50 to 90% predicted (PEF)
Key exclusion criteria (8 listed)
- History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1.
- Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia).
- Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose).
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 |
|---|---|---|
| GW685698X (fluticasone furoate) 100mcg MorningGW685698X inhaled once daily in the morning plus placebo in the evening for 28 days | Drug | GW685698X (fluticasone furoate) 100mcg Morning, Placebo |
| GW685698X (fluticasone furoate) 100mcg EveningGW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days | Drug | GW685698X (fluticasone furoate) 100mcg Evening, Placebo |
| GW685698X (fluticasone furoate) 250mcg EveningGW685698X inhaled once daily in the evening plus placebo in the morning for 28 days | Drug | GW685698X (fluticasone furoate) 250mcg Evening, Placebo |
| PlaceboPlacebo inhaled twice daily (morning and evening) for 28 days | Drug | Placebo |
Primary outcome
Peak expiratory flow (PEF)
Time frame: 28 days
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.
3 secondary outcomes
Peak expiratory flow (PEF)
Time frame: 28 days
PEF
Time frame: 28 days
Clinic lung function
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- 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.
- Derived from this study: PubMed 22796247Medley H, Orozco S, Allen A. Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma. Clin Ther. 2012 Aug;34(8):1683-95. doi: 10.1016/j.clinthera.2012.06.024. Epub 2012 Jul 13.
- 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
64 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW685698X (fluticasone furoate) 100mcg Morning, GW685698X (fluticasone furoate) 100mcg Evening and GW685698X (fluticasone furoate) 250mcg Evening in people with Asthma, run by GlaxoSmithKline at 64 sites in 13 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 6 inclusion and 8 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Germany, Italy, Russia, Bulgaria, Estonia and 8 more countries. 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?
Peak expiratory flow (PEF) (time frame: 28 days). 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 NCT01499446, 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 15 Sep 2016.