AsthmaPhase 4NCT01192178
Fall Epidemic Viral Pediatric Study
A Phase 4 study testing FLOVENT™ DISKUS™ 100 mcg BID and ADVAIR™ DISKUS™ 100/50 mcg BID in people with Asthma, run by GlaxoSmithKline at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- FLOVENT™ DISKUS™ 100 mcg BID and ADVAIR™ DISKUS™ 100/50 mcg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 38 sitesUnited States
- Study dates
- Aug 2010to Dec 2010
- Phase
- Phase 4
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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]
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- 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:
- Subjects who have had prior use of a controller medication consisting of a low dose ICS at any time since September 1st, 2009 are eligible for inclusion in this study (refer to Table 1 for examples of allowed doses of commonly used ICS).
- Subjects currently taking a low dose ICS are eligible for inclusion in the study (refer to Table 1 for examples of allowed doses of commonly used ICS).
- Subjects' currently taking a moderate dose ICS are eligible for inclusion in the study if the subject's asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines [NIH, 2007].
- Subjects' currently taking low dose ICS in combination with a LABA are eligible for inclusion in the study if the subject's asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines [NIH, 2007].
- 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.
Who cannot join
- 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).
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- 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.
- Investigational Medications: A subject must not have participated in a study (including a non-interventional study) or used any investigational drug (including devices) within 30 days prior to Visit 1 or within ten half-lives (t1/2) of the prior investigational study (whichever is longer of the two).
- Child in Care: A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The determination of whether a child meets the definition of CiC should be made with the study centre staff in consultation with the responsible IRB/Ethics Committee.
- Affiliation with Investigator's Site: A subject is an immediate family member of the participating investigator, sub investigator, study coordinator, or employee of the participating investigator.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
GSK Investigational Site
Albuquerque, New Mexico, 87131
GSK Investigational Site
Asheville, North Carolina, 28801
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
Boerne, Texas, 78006
GSK Investigational Site
Brick, New Jersey, 08724
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Collegeville, Pennsylvania, 19426
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Gainesville, Georgia, 30501
GSK Investigational Site
Granada Hills, California, 91344
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
Norfolk, Virginia, 23507
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Sacramento, California, 95819
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
St. Petersburg, Florida, 33710
GSK Investigational Site
Summerville, South Carolina, 29485
GSK Investigational Site
Tucson, Arizona, 85724
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Ypsilanti, Michigan, 48197
About this study
Official title: 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.
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.
Read the detailed description
Study ADA113872 will assess the ability of ADVAIR™ DISKUS™ 100/50 mcg, in comparison to FLOVENT™ DISKUS™ 100 mcg, to reduce worsening asthma associated with viral respiratory infections during the fall season in a pediatric population. A number of descriptive measures will be used to assess the reduction in worsening asthma. These include the number of exacerbations, the duration and severity of asthma symptoms in the 7 days following the report of moderate upper respiratory tract symptoms or worsening asthma, the number of rescue-free days, and the rate of asthma control days.
Subjects will be identified starting in April 2010 to evaluate whether they meet the eligibility criteria. If a subject is identified as a potential candidate for the study they will be requested to return to the clinic between August 2, 2010 and August 20, 2010. Subjects who meet all inclusion and none of the exclusion criteria will be entered into the study. All subjects must be randomized on or before August 20th, 2010.
Subjects will be males and females who are between the ages of 4 and 11 years (as of randomization date) with a documented diagnosis of asthma requiring ICS monotherapy controller medication or low dose ICS as part of combination controller medication. In order for a subject on moderate dose ICS or low dose ICS + LABA combination therapy to be eligible for inclusion in this study their asthma must be under control for the 3 months prior to randomization and they must be a candidate for step-down therapy as outlined by current asthma management guidelines.
All subjects must have a history of one or more exacerbations during the previous respiratory viral season that required the use of outpatient oral/parenteral corticosteroid or an urgent care, Emergency Department visit hospitalization, or for asthma that required the use of oral/parenteral corticosteroid.
Subjects will receive their study medication at the Randomization visit and be instructed to keep an electronic daily record of AM PEF, asthma symptoms, night-time awakenings due to asthma, rescue use, and upper respiratory tract infection symptoms.
During the double-blind treatment period the electronic Diary (eDiary) will alert the subject or parent/legal guardian when the data imputed into the eDiary indicates the presence of upper respiratory symptoms of moderate or severe severity or if the subject has reached the criteria for worsening asthma. Upon receipt of either of these alerts, the subject or parent/legal guardian will be instructed to call the clinic. The clinic will instruct the subject (parent/legal guardian) to provide a mucus sample for assessment of viral respiratory infection. Mucus samples for viral respiratory assessment will not be collected from subjects more than once in a 7 day period. During the randomization visit subjects will receive training on the at home collection of a mucus sample.
Throughout the study each subject will be instructed to rate their daily upper respiratory symptoms. Upper respiratory tract symptoms include: runny nose, sneezing, nasal congestion, and sore throat. Subjects will be instructed to select a rating from the following list that best describes their aggregate upper respiratory symptoms during the previous 24 hours.
This study will evaluate the effects of the ADVAIR™ DISKUS™ 100/50 mcg and FLOVENT™ DISKUS™ 100 mcg on clinical parameters and indices of airway inflammation associated with viral respiratory tract infections in pediatric asthmatic subjects. Safety will be assessed by monitoring adverse events.
- Conditions
- Asthma
- Being tested
- FLOVENT™ DISKUS™ 100 mcg BID, ADVAIR™ DISKUS™ 100/50 mcg BID
- Keywords
- pediatric, exacerbation, viral induced exacerbation, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOVENT™ DISKUS™ 100 mcg BIDDrug
Also called Fluticasone propionate
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 BIDDrug
Also called Fluticasone propionate/salmeterol combination
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).
| Study group | Role | What they receive |
|---|---|---|
| FLOVENT™ DISKUS™ 100 mcg | Active comparator | FLOVENT™ 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. Receives: Drug: FLOVENT™ DISKUS™ 100 mcg BID |
| ADVAIR™ DISKUS™ 100/50 mcg | Experimental | ADVAIR™ 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. Receives: Drug: ADVAIR™ DISKUS™ 100/50 mcg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants recorded their asthma symptom score over the previous 24 hours (during the day and the previous night) using the following 6-point scale: 0=No symptoms; 1=Symptoms for 1 short period; 2=Symptoms for >=2 short periods; 3=Symptoms for most of the day/previous night that did not affect normal daily activities; 4=Symptoms for most of the day/previous night that affected normal daily activities; 5=Symptoms so severe that participant could not perform normal daily activities. The Baseline mean asthma symptom score was calculated as the average score over 7 days prior to Week 1, Visit 2.
Measured: 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
A worsening asthma day is one on which any of the following occurred: rescue albuterol use above baseline, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study medication, asthma symptom scores >=3, nighttime awakenings, unscheduled health care visits, or missed school due to asthma. The duration of worsening asthma is the number of consecutive worsening asthma days after the date of a URTS score of 2 (moderate) or 3 (severe) or collection of a mucus sample containing RV (whichever occurred first). Each span of consecutive days is a participant interval.
Measured: 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
Each participant (with assistance from the parent/legal guardian as needed) was instructed to keep an electronic diary (eDiary) with record of daily URTS symptoms that included: runny nose, sneezing, nasal congestion, and sore throat. Based on the best-described aggregate URTS during the previous 24 hours, participants rated symptoms as: 0 = Not present; 1 = Mild, clearly present; 2 = Moderately severe, uncomfortable; and 3 = Severe, interfering with sleep or activity. Mucus samples were collected and analyzed for RVwhen the eDiary alerted for moderate/severe URTS.
Measured: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Asthma-control Days
An asthma-control day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than double-blind study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, or school absenteeism due to asthma. The percentage of asthma-control days = the number (No.) of asthma-control days divided by the No. of days of treatment exposure, multiplied by 100.
Measured: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Episode-free (EF) Days
An EF day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, school absenteeism due to asthma, or morning peak expiratory flow (measure of maximum airflow) <80% of baseline. Percentage of EF days=No. of EF days divided by No. of days of treatment exposure, multiplied by 100.
Measured: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Symptom-free Days
A symptom-free day was defined as a day during the Peak Viral Period on which the asthma symptom score was zero. The daily asthma symptom score (measured during the day and the previous night) was reported on a 6-point scale (ranging from 0=no symptoms to 5=severe symptoms). Percentage of symptom-free days was defined as the number of days during the Peak Viral Period on which the asthma symptom score=0, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.
Measured: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Rescue-free Days
A rescue-free day was defined as a day during the Peak Viral Period on which no puffs of rescue medication were recorded. Percentage of rescue-free days was defined as the number of days during the Peak Viral Period on which no puffs of rescue medication were recorded, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.
Measured: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
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 (1)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 339 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
- NCT01192178
- Sponsor's protocol ID
- 113872
- Status last verified
- Nov 2016
- First submitted
- 15 Jul 2010
- Last updated
- 18 Jan 2017
- 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
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.
PubMed 26289742
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01192178
- Acronym / sponsor ID
- 113872
- Conditions
- Asthma
- Keywords
- pediatric, exacerbation, viral induced exacerbation, asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 3 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study ADA113872 will assess the ability of ADVAIR™ DISKUS™ 100/50 mcg, in comparison to FLOVENT™ DISKUS™ 100 mcg, to reduce worsening asthma associated with viral respiratory infections during the fall season in a pediatric population. A number of descriptive measures will be used to assess the reduction in worsening asthma. These include the number of exacerbations, the duration and severity of asthma symptoms in the 7 days following the report of moderate upper respiratory tract symptoms or worsening asthma, the number of rescue-free days, and the rate of asthma control days.
Subjects will be identified starting in April 2010 to evaluate whether they meet the eligibility criteria. If a subject is identified as a potential candidate for the study they will be requested to return to the clinic between August 2, 2010 and August 20, 2010. Subjects who meet all inclusion and none of the exclusion criteria will be entered into the study. All subjects must be randomized on or before August 20th, 2010.
Subjects will be males and females who are between the ages of 4 and 11 years (as of randomization date) with a documented diagnosis of asthma requiring ICS monotherapy controller medication or low dose ICS as part of combination controller medication. In order for a subject on moderate dose ICS or low dose ICS + LABA combination therapy to be eligible for inclusion in this study their asthma must be under control for the 3 months prior to randomization and they must be a candidate for step-down therapy as outlined by current asthma management guidelines.
All subjects must have a history of one or more exacerbations during the previous respiratory viral season that required the use of outpatient oral/parenteral corticosteroid or an urgent care, Emergency Department visit hospitalization, or for asthma that required the use of oral/parenteral corticosteroid.
Subjects will receive their study medication at the Randomization visit and be instructed to keep an electronic daily record of AM PEF, asthma symptoms, night-time awakenings due to asthma, rescue use, and upper respiratory tract infection symptoms.
During the double-blind treatment period the electronic Diary (eDiary) will alert the subject or parent/legal guardian when the data imputed into the eDiary indicates the presence of upper respiratory symptoms of moderate or severe severity or if the subject has reached the criteria for worsening asthma. Upon receipt of either of these alerts, the subject or parent/legal guardian will be instructed to call the clinic. The clinic will instruct the subject (parent/legal guardian) to provide a mucus sample for assessment of viral respiratory infection. Mucus samples for viral respiratory assessment will not be collected from subjects more than once in a 7 day period. During the randomization visit subjects will receive training on the at home collection of a mucus sample.
Throughout the study each subject will be instructed to rate their daily upper respiratory symptoms. Upper respiratory tract symptoms include: runny nose, sneezing, nasal congestion, and sore throat. Subjects will be instructed to select a rating from the following list that best describes their aggregate upper respiratory symptoms during the previous 24 hours.
This study will evaluate the effects of the ADVAIR™ DISKUS™ 100/50 mcg and FLOVENT™ DISKUS™ 100 mcg on clinical parameters and indices of airway inflammation associated with viral respiratory tract infections in pediatric asthmatic subjects. Safety will be assessed by monitoring adverse events.
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 |
|---|---|---|
| FLOVENT™ DISKUS™ 100 mcg | Active comparator | Drug: FLOVENT™ DISKUS™ 100 mcg BIDFLOVENT™ 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 | Experimental | Drug: ADVAIR™ DISKUS™ 100/50 mcg BIDADVAIR™ 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (18 listed)
- 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,
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 |
|---|---|---|
| FLOVENT™ DISKUS™ 100 mcg BIDAlso: Fluticasone propionateFLOVENT™ DISKUS™ 100 mcg, one inhalation twice daily (BID) from the DISKUS device from randomization through the end of study (week 16). | Drug | FLOVENT™ DISKUS™ 100 mcg |
| ADVAIR™ DISKUS™ 100/50 mcg BIDAlso: Fluticasone propionate/salmeterol combinationADVAIR™ 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). | Drug | ADVAIR™ DISKUS™ 100/50 mcg |
Primary outcome
Total Number of Asthma Exacerbations Reported During the Treatment Period
Time frame: From Baseline (Week 1) until the end of treatment (up to Week 16)
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.
7 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Asthma-control Days
Time frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Episode-free (EF) Days
Time frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Symptom-free Days
Time frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Mean Percentage of Rescue-free Days
Time frame: Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26289742Prazma 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.
- National Health Lung and Blood Institute Asthma GuidelinesLink 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
38 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 FLOVENT™ DISKUS™ 100 mcg BID and ADVAIR™ DISKUS™ 100/50 mcg BID in people with Asthma, run by GlaxoSmithKline at 38 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 19 inclusion and 18 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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?
Yes. Results are posted in the registry (first posted 3 Nov 2011). 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?
Total Number of Asthma Exacerbations Reported During the Treatment Period (time frame: From Baseline (Week 1) until the end of treatment (up to Week 16)). 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 NCT01192178, which also lists 1 linked publication.
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 18 Jan 2017.