AsthmaPhase 3NCT01086384
Asthma Exacerbation Study
A Phase 3 study testing Fluticasone Furoate/GW642444 and Fluticasone furoate in people with Asthma, run by GlaxoSmithKline at 183 sites in 11 countries.
Trial summary
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Furoate/GW642444 and Fluticasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,020 participants
- Where
- 183 sitesin 11 countries
- Study dates
- 22 Feb 2010to 15 Sep 2011
- Phase
- Phase 3
- 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 FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- FEV1 of fifty to ninety percent of predicted
- Currently using inhaled corticosteroid therapy
- History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year
Who cannot join
- History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
- Respiratory infection or oral candidiasis
- - Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
Trial locations and contacts
183 sites in 11 countries.
183 sites in 11 countries
United States64 sites
GSK Investigational Site
Albany, Georgia, 31707
GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bell Gardens, California, 90201
GSK Investigational Site
Bellingham, Washington, 98225
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cocoa, Florida, 32927
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Collegeville, Pennsylvania, 19426
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Fresno, California, 93721
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Hazard, Kentucky, 41701
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Indianapolis, Indiana, 46256
GSK Investigational Site
Killeen, Texas, 76542
GSK Investigational Site
Knoxville, Tennessee, 37909
GSK Investigational Site
La Crosse, Wisconsin, 54601
GSK Investigational Site
Lawrenceville, Georgia, 30046
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Napa, California, 94558
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Oxford, Alabama, 36203
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, 19115
GSK Investigational Site
Phoenix, Arizona, 85016
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Rancho Mirage, California, 92270
GSK Investigational Site
River Forest, Illinois, 60305
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rockville Centre, New York, 11570
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
Scottsdale, Arizona, 85251
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Stockton, California, 95207
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Sylvania, Ohio, 43560
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Torrance, California, 90505
GSK Investigational Site
Tucson, Arizona, 85724-5073
GSK Investigational Site
Union, South Carolina, 29379
GSK Investigational Site
Valrico, Florida, 33596
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
Winter Park, Florida, 32789
Germany28 sites
GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44787
GSK Investigational Site
Cottbus, Brandenburg, 03050
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44263
GSK Investigational Site
Erfurt, Thuringia, 99084
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Frankfurt am Main, Hesse, 60389
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Großheirath, Bavaria, 96269
GSK Investigational Site
Hamburg, 20357
GSK Investigational Site
Hamburg, 22299
GSK Investigational Site
Hamburg, 22335
GSK Investigational Site
Hamburg, 22767
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Leipzig, Saxony, 04275
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Marburg, Hesse, 35037
GSK Investigational Site
Potsdam, Brandenburg, 14469
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42651
GSK Investigational Site
Vilshofen, Bavaria, 94474
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Witten, North Rhine-Westphalia, 58452
Russia16 sites
GSK Investigational Site
Barnaul, 656 045
GSK Investigational Site
Blagoveshchensk, 675000
GSK Investigational Site
Chelyabinsk, 454106
GSK Investigational Site
Kazan', 420015
GSK Investigational Site
Krasnodar
GSK Investigational Site
Novosibirsk, 630047
GSK Investigational Site
Novosibirsk, 630087
GSK Investigational Site
Penza, 440067
GSK Investigational Site
Perm, 614077
GSK Investigational Site
Pyatigorsk, 357538
GSK Investigational Site
Saint Petersburg, 194354
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Saratov, 410028
GSK Investigational Site
Tomsk, 634001
GSK Investigational Site
Volgodonsk, 347381
GSK Investigational Site
Voronezh, 394018
Poland15 sites
GSK Investigational Site
Bydgoszcz, 85-681
GSK Investigational Site
Dębica, 39-200
GSK Investigational Site
Gdansk, 80-169
GSK Investigational Site
Kielce
GSK Investigational Site
Koszalin
GSK Investigational Site
Krakow, 31-159
GSK Investigational Site
Lublin, 20-089
GSK Investigational Site
Lublin, 20-954
GSK Investigational Site
Olsztyn, 10-357
GSK Investigational Site
Poznan, 60-214
GSK Investigational Site
Poznan, 60-693
GSK Investigational Site
Rzeszów
GSK Investigational Site
Wołomin, 05-200
GSK Investigational Site
Wroclaw, 50-445
GSK Investigational Site
Wroclaw, 54-239
Japan14 sites
GSK Investigational Site
Fukuoka, 802-0052
GSK Investigational Site
Fukuoka, 832-0059
GSK Investigational Site
Hokkaido, 064-0801
GSK Investigational Site
Kagoshima, 890-0064
GSK Investigational Site
Kagoshima, 892-0844
GSK Investigational Site
Kanagawa, 252-0143
GSK Investigational Site
Kyoto, 601-8206
GSK Investigational Site
Kyoto, 612-0026
GSK Investigational Site
Saitama, 343-0808
GSK Investigational Site
Tokyo, 113-0031
GSK Investigational Site
Tokyo, 153-0051
GSK Investigational Site
Tokyo, 187-0024
GSK Investigational Site
Tokyo, 190-0013
GSK Investigational Site
Tokyo, 204-0021
Ukraine14 sites
GSK Investigational Site
Dnipropetrovsk, 49051
GSK Investigational Site
Donetsk, 83017
GSK Investigational Site
Kyiv, 02091
GSK Investigational Site
Kyiv, 02660
GSK Investigational Site
Kyiv, 03038
GSK Investigational Site
Kyiv, 03115
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Kyiv, 04050
GSK Investigational Site
Kyiv, 04201
GSK Investigational Site
Simferopol, 95034
GSK Investigational Site
Vinnytsia, 21029
GSK Investigational Site
Yalta, 98603
GSK Investigational Site
Zaporizhia, 69063
GSK Investigational Site
Zaporizhia, 69076
Argentina9 sites
GSK Investigational Site
Buenos Aires, C1121ABE
GSK Investigational Site
Buenos Aires, C1424BSF
GSK Investigational Site
Buenos Aires, C1425BEN
GSK Investigational Site
Buenos Aires, C1426ABP
GSK Investigational Site
Mendoza, M5500CCG
GSK Investigational Site
Paraná, Entre Ríos Province, E3100BHK
GSK Investigational Site
Quilmes, Buenos Aires, B1878FNR
GSK Investigational Site
Rosario, Santa Fe Province, S2000DSR
GSK Investigational Site
San Miguel de Tucumán, 4000
Australia6 sites
GSK Investigational Site
Auchenflower, Queensland, 4066
GSK Investigational Site
Blacktown, New South Wales, 2148
GSK Investigational Site
Clayton, Victoria, 3168
GSK Investigational Site
Garran, Australian Capital Territory, 2606
GSK Investigational Site
Hornsby, New South Wales, 2077
GSK Investigational Site
Toorak Gardens, South Australia, 5065
Mexico6 sites
GSK Investigational Site
Guadalajara, Jalisco, 44100
GSK Investigational Site
Mexico City, 04530
GSK Investigational Site
Mexico City, 07760
GSK Investigational Site
Monterrey NL, Nuevo León, 64718
GSK Investigational Site
Villahermosa, Tabasco, 86100
GSK Investigational Site
Zapopan, Jalisco, 45040
Romania6 sites
GSK Investigational Site
Bucharest, 020674
GSK Investigational Site
Bucharest, 050159
GSK Investigational Site
Craiova, 200341
GSK Investigational Site
Deva, 330084
GSK Investigational Site
Piteşti, 110084
GSK Investigational Site
Sibiu, 550166
Philippines5 sites
GSK Investigational Site
Iloilo City, 5000
GSK Investigational Site
Lipa City, 4217
GSK Investigational Site
Marilao, Bulacan, 3019
GSK Investigational Site
Quezon City, 1101
GSK Investigational Site
Quezon City, 1109
About this study
Official title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
- Conditions
- Asthma
- Being tested
- Fluticasone Furoate/GW642444, Fluticasone furoate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate/GW642444Drug
Combination inhaled corticosteroid and long-acting beta2-agonist
Fluticasone furoateDrug
Inhaled corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone furoate/GW642444 | Experimental | Not described Receives: Drug: Fluticasone Furoate/GW642444 |
| fluticasone furoate | Experimental | Not described Receives: Drug: Fluticasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 1 or More Severe Asthma Exacerbations
Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.
Measured: Baseline to Follow-up (up to 76 weeks of treatment)
Secondary outcomes (2)
Number of Severe Asthma Exacerbations
A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.
Measured: Baseline to Follow-up (up to 76 weeks of treatment)
Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36
Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.
Measured: Baseline and Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study start22 Feb 2010
- Primary completion1 Sep 2011
- Study completion15 Sep 2011
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 (3)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,020 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
- NCT01086384
- Sponsor's protocol ID
- 106837
- Status last verified
- Jan 2018
- First submitted
- 11 Mar 2010
- Last updated
- 24 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 27881132Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.
PubMed 26704701Bateman ED, O'Byrne PM, Busse WW, Lotvall J, Bleecker ER, Andersen L, Jacques L, Frith L, Lim J, Woodcock A. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014 Apr;69(4):312-9. doi: 10.1136/thoraxjnl-2013-203600. Epub 2013 Nov 19.
PubMed 24253831
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT01086384
- Acronym / sponsor ID
- 106837
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,020 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2010
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- 15 Sep 2011 (actual)
- First posted
- 15 Mar 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.
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone furoate/GW642444 | Experimental | Drug: Fluticasone Furoate/GW642444 |
| fluticasone furoate | Experimental | Drug: Fluticasone furoate |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of asthma
- Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- FEV1 of fifty to ninety percent of predicted
- Currently using inhaled corticosteroid therapy
- History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year
Key exclusion criteria (5 listed)
- History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
- Respiratory infection or oral candidiasis
- - Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
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/GW642444Combination inhaled corticosteroid and long-acting beta2-agonist | Drug | Fluticasone furoate/GW642444 |
| Fluticasone furoateInhaled corticosteroid | Drug | fluticasone furoate |
Primary outcome
Number of Participants With 1 or More Severe Asthma Exacerbations
Time frame: Baseline to Follow-up (up to 76 weeks of treatment)
Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.
2 secondary outcomes
Number of Severe Asthma Exacerbations
Time frame: Baseline to Follow-up (up to 76 weeks of treatment)
Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36
Time frame: Baseline and Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 26704701Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.
- Derived from this study: PubMed 24253831Bateman ED, O'Byrne PM, Busse WW, Lotvall J, Bleecker ER, Andersen L, Jacques L, Frith L, Lim J, Woodcock A. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014 Apr;69(4):312-9. doi: 10.1136/thoraxjnl-2013-203600. Epub 2013 Nov 19.
- 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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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
183 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone Furoate/GW642444 and Fluticasone furoate in people with Asthma, run by GlaxoSmithKline at 183 sites in 11 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 5 inclusion and 5 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 183 sites in United States, Germany, Russia, Poland, Japan and 6 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. 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?
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?
Number of Participants With 1 or More Severe Asthma Exacerbations (time frame: Baseline to Follow-up (up to 76 weeks of treatment)). 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 NCT01086384, which also lists 3 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 24 Jan 2018.