Fall Epidemic Viral Pediatric Study
A Randomized, Double-Blind, Parallel Group Study of ADVAIR™ DISKUS™ 100/50 and FLOVENT™DISKUS™ 100, Both Twice Daily, in a Pediatric Population During the Fall Viral Season.
1 other identifier
interventional
339
1 country
38
Brief Summary
Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment starting in April 2010. Eligible subjects will be invited to return for randomization into the study in August 2010. This exploratory study is being conducted to assess whether treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of exacerbation and the asthma impairment associated with viral respiratory tract infections during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Aug 2010
Shorter than P25 for phase_4 asthma
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
November 3, 2011
CompletedJanuary 18, 2017
November 1, 2016
4 months
July 15, 2010
September 29, 2011
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Number of Asthma Exacerbations Reported During the Treatment Period
An asthma exacerbation was defined as deterioration of asthma that required the use of outpatient oral/parenteral corticosteroids (tablets, suspensions, or injection) or an urgent care, hospitalization, or emergency room (ER) visit due to asthma that required oral/parenteral corticosteroids. Two exacerbations (out of a total of 51) were excluded: (1) one exacerbation occurred within 7 days of the resolution of an earlier one, and, per protocol, was combined with the previous exacerbation; and (2) one exacerbation occurred post treatment.
From Baseline (Week 1) until the end of treatment (up to Week 16)
Secondary Outcomes (7)
Mean Asthma Symptom Scores, as an Indicator of Severity, Associated With the Presence of Moderate or Severe Upper Respiratory Tract Symptoms (URTS) or a Confirmed Rhinovirus (RV) Infection at Baseline and During the Peak Viral Period
Baseline (Week 1) and Peak Viral Period ([period during which the greatest number of viral infections is expected] from 30 August 2010 through the end of the treatment period [up to Week 16])
Mean Duration of Worsening Asthma Symptoms Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection
Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Number of Asthma Exacerbations Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection During the Peak Viral Period
Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Asthma-control Days
Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Episode-free (EF) Days
Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
- +2 more secondary outcomes
Study Arms (2)
FLOVENT™ DISKUS™ 100 mcg
ACTIVE COMPARATORFLOVENT™ DISKUS™ 100 mcg is an inhaled corticosteroid indicated in the US for maintenance treatment of asthma as prophylactic therapy in patients 4 years and older.
ADVAIR™ DISKUS™ 100/50 mcg
EXPERIMENTALADVAIR™ DISKUS™ 100/50 mcg is a combination product containing a corticosteroid and a long acting beta2 adrenergic agonist indicated for; maintenance treatment of asthma in patients 4 years of age and older.
Interventions
FLOVENT™ DISKUS™ 100 mcg, one inhalation twice daily (BID) from the DISKUS device from randomization through the end of study (week 16).
ADVAIR™ DISKUS™ 100/50 mcg is a combination product containing a 100 mcg fluticasone propionate and a 50 mcg salmeterol. One inhalation from the DISKUS device twice daily (BID) from randomization through end of study (week 16).
Eligibility Criteria
You may qualify if:
- Outpatient
- Subjects must be between the ages of 4 and 11 at Randomization
- Subjects must attend day-care, pre-school, elementary school, or middle school. Day-care attendance is defined as receiving childcare outside the home for at least 10 hours per week. Children who are home-schooled are not eligible for this study. Children on year round and traditional school calendars are eligible for this study.
- Subjects can be randomized into this study at any time between August 2nd, 2010 and August 20th, 2010.
- Males or pre-menarchal females.
- A diagnosis of asthma, as defined by the National Institutes of Health \[NIH, 2007\]
- At Visit 1 subjects must demonstrate a best clinic AM PEF ≥70% of the predicted value \[Polgar, 1971\].
- Each subject must have a history of an exacerbation of asthma between September 1st, 2009 and May 15th, 2010 that required a burst of outpatient systemic corticosteroids (oral or parenteral on \>1 days for worsening symptoms of asthma) or have had an urgent care, hospitalization, or ED visit for asthma during which they received oral/parenteral corticosteroids between September 1st, 2009 and May 15th, 2010.
- Subjects must have prior or current use of controller ICS medication as listed below:
- All subjects must be able to replace their short-acting beta2-agonists with study-issued albuterol inhalation aerosol at Visit 1 for use as needed for the duration of the study. If a subject demonstrates the inability to coordinate the use of an MDI alone, subjects are permitted to use an Aerochamber Plus spacer. The use or non-use of a spacer for albuterol inhalation aerosol should be consistent for each subject throughout the study. Subjects must be able to withhold inhaled albuterol for at least 6 hours prior to study Visits
- Chickenpox: Reported history of clinical varicella or varicella vaccine. If a subject needs varicella vaccine this will be arranged with a physician and must be received prior to randomization.
- Electronic Peak Flow Meter (ePEF)/Electronic Daily Diary (eDiary): A subject must be able to use the study-provided electronic peak flow meter and the subject/caregiver must be able to enter data using the electronic Diary record.
- Responsibilities of Consenting Parent/Legal Guardian: The subject's parent or legal guardian must commit to assist the subject at a consistent level with administration of investigational product and electronic Diary device and electronic PEF meter throughout the study.
- A subject must demonstrate adequate and appropriate technique for using the DISKUS™ device reliably.
- Fluency in English or USA Spanish: Subject and/or subject's parent/guardian must be able to read, comprehend, and record information in English or USA Spanish.
You may not qualify if:
- History of Life Threatening Asthma
- Unstable Asthma
- Concomitant use of corticosteroid medication
- Other Concurrent Diseases/Abnormalities: The known presence of sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within 4 weeks immediately preceding randomization that required the use of an antibiotic or was accompanied by symptoms of worsening asthma.
- Concomitant Medications: Administration of any other prescription or over the counter medication which would significantly affect the course of asthma, such as omalizumab (Xolair), or interact with sympathomimetic amines, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine), polycyclic antidepressants, beta-adrenergic blocking agents (both cardio-selective and non-selective), phenothiazines,
- Cytochrome P450 3A4 (CYP 3A4) Inhibitors: A subject is not eligible if he/she is receiving a strong CYP 3A4 inhibitor within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
- Immunosuppressive medications: A subject must not be using or require use of immunosuppressive medications (e.g. methotrexate, gold, cyclosporine, azathioprine) during the study.
- Note: Immunotherapy for the treatment of allergies is allowed during the study provided it was initiated 4 weeks prior to Visit 1 and the subject remains in the maintenance phase for the duration of the study.
- Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, cystic fibrosis, dyspnea by any cause other than asthma, or other respiratory abnormalities other than asthma.
- Other Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
- The list of additional excluded conditions/diseases includes, but is not limited to the following:
- Uncontrolled hypertension; Uncontrolled hematologic, hepatic, neurologic, or renal disease Uncontrolled gastroesophageal reflux disease, Immunologic compromise, Cardiac arrhythmias, Tuberculosis (current or untreated), Congestive heart failure, Cushing's disease Coronary artery disease, Addison's disease, Current malignancy, Eosinophilic esophagitis Uncontrolled diabetes mellitus, Uncontrolled thyroid disorder
- Severe Hypersensitivity to Milk Proteins: Any immediate hypersensitivity reaction, such as urticaria, angioedema, rash, and bronchospasm to milk proteins
- Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the Dry Powder Inhaler (i.e., lactose).
- Tobacco Use: A history of or present use of any tobacco products.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (38)
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Granada Hills, California, 91344, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 95819, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Brick, New Jersey, 08724, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Collegeville, Pennsylvania, 19426, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Summerville, South Carolina, 29485, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
Murray, Utah, 84107, United States
GSK Investigational Site
Norfolk, Virginia, 23507, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
Related Publications (1)
Prazma CM, Gern JE, Weinstein SF, Prillaman BA, Stempel DA. The association between seasonal asthma exacerbations and viral respiratory infections in a pediatric population receiving inhaled corticosteroid therapy with or without long-acting beta-adrenoceptor agonist: a randomized study. Respir Med. 2015 Oct;109(10):1280-6. doi: 10.1016/j.rmed.2015.06.010. Epub 2015 Jun 24.
PMID: 26289742DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2010
First Posted
August 31, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 18, 2017
Results First Posted
November 3, 2011
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.