AsthmaPhase 4NCT00296530

Study Of Patients With Allergic Rhinitis And Asthma

A Phase 4 study testing fluticasone propionate/salmeterol, fluticasone propionate and montelukast in people with Asthma, run by GlaxoSmithKline at 80 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

This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Asthma
What is being tested?: fluticasone propionate/salmeterol, fluticasone propionate and montelukast
How many people: 600 participants
Where: 80 sitesUnited States
Study dates: Sep 2005to Jul 2007
Phase: Phase 4
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Have asthma for at least 3 months prior to the study.
Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
Have a positive allergy skin test.

Who cannot join

Have a history of life-threatening asthma.
Been hospitalized for asthma within the 6 months prior to the study.
Have certain conditions that would make study participation unsafe.
The study doctor will evaluate other inclusion and exclusion criteria.

Trial locations and contacts

80 sites in 1 country.

City, postcode or hospital

80 sites in 1 country

United States80 sites

GSK Investigational Site
Austin, Texas, 78704
GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Charleston, South Carolina, 29414
GSK Investigational Site
Charlotte, North Carolina, 28204
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Chattanooga, Tennessee, 37421
GSK Investigational Site
Chevy Chase, Maryland, 20815
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Collegeville, Pennsylvania, 19426
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dallas, Texas, 75231-4307
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
El Paso, Texas, 79902
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Gibsonia, Pennsylvania, 15044
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Houston, Texas, 77070
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Ithaca, New York, 14850
GSK Investigational Site
Kenilworth, Illinois, 60043
GSK Investigational Site
Killeen, Texas, 76542
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Lilburn, Georgia, 30047
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Los Angeles, California, 90095-1752
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
North Andover, Massachusetts, 01845
GSK Investigational Site
North Olmsted, Ohio, 44070
GSK Investigational Site
Ocean City, New Jersey, 07712
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Ozark, Alabama, 36360
GSK Investigational Site
Palmdale, California, 93551
GSK Investigational Site
Philadelphia, Pennsylvania, 19115
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Providence, Rhode Island, 02906
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
San Jose, California, 95128
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Skillman, New Jersey, 08558
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
Stockton, California, 95207
GSK Investigational Site
Sylvania, Ohio, 43560
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Tempe, Arizona, 85282
GSK Investigational Site
Vista, California, 92083
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
West Jordan, Utah, 84084
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Read the detailed description

A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Conditions: Asthma
Being tested: fluticasone propionate/salmeterol, fluticasone propionate, montelukast
Keywords: Asthma, Allergic Rhinitis
Medical subject headings: Asthma, Rhinitis, Allergic

What participants receive

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

fluticasone propionate/salmeterolDrug
fluticasone propionateDrug
montelukastDrug
Also called fluticasone propionate/salmeterol, fluticasone propionate

What is being measured

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

Morning Peak Expiratory Flow

Secondary outcomes (1)

Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days

Timeline

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

Sep 2005Jul 2007

First posted27 Feb 2006 (estimated)
Study startSep 2005
Primary completionJul 2007
Study completionJul 2007

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00296530
Sponsor's protocol ID: ADA103578
Status last verified: Oct 2016
First submitted: 23 Feb 2006
Last updated: 28 Oct 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

This study has not been published in the scientific literature.
Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, Ortega HG. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy Asthma Proc. 2010 Jan-Feb;31(1):68-75. doi: 10.2500/aap.2010.31.3306.
PubMed 20167147

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

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

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
ClinicalTrials.gov ID: NCT00296530
Acronym / sponsor ID: ADA103578
Conditions: Asthma
Keywords: Asthma, Allergic Rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 27 Feb 2006 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Have asthma for at least 3 months prior to the study.
Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
Have a positive allergy skin test.

Key exclusion criteria (4 listed)

Have a history of life-threatening asthma.
Been hospitalized for asthma within the 6 months prior to the study.
Have certain conditions that would make study participation unsafe.
The study doctor will evaluate other inclusion and exclusion criteria.

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 propionate/salmeterol	Drug	–
fluticasone propionate	Drug	–
montelukastAlso: fluticasone propionate/salmeterol, fluticasone propionate	Drug	–

Primary outcome

Morning Peak Expiratory Flow

1 secondary outcome

Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free 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 28 Oct 2016.
BackgroundThis study has not been published in the scientific literature.
Derived from this study: PubMed 20167147Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, Ortega HG. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy Asthma Proc. 2010 Jan-Feb;31(1):68-75. doi: 10.2500/aap.2010.31.3306.
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.

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

80 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fluticasone propionate/salmeterol, fluticasone propionate and montelukast in people with Asthma, run by GlaxoSmithKline at 80 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 4 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Morning Peak Expiratory Flow. 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 NCT00296530, 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 28 Oct 2016.