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BronchospasmPhase 4NCT00118716

A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

A Phase 4 study testing Fluticasone propionate/salmeterol and Fluticasone Propionate in people with Bronchospasm and Activity/Exercise Induced Bronchospasm, run by GlaxoSmithKline at 50 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

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. Read more about this study

Who is it for?
Ages 4 to 17 years
What is being tested?
Fluticasone propionate/salmeterol and Fluticasone Propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
50 sitesUnited States
Study dates
23 Dec 2003to 23 Apr 2006
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosed with persistent asthma for 3 months or longer.
  • Experienced worsened asthma symptoms during physical activity.
  • Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

Who cannot join

  • Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
  • Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
  • Admitted to a hospital within the previous 6 months due to asthma symptoms.
  • Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.)
  • The study physician will evaluate other medical criteria.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Commack, New York, 11725

  • GSK Investigational Site

    Dallas, Texas, 75204

  • GSK Investigational Site

    Dayton, Ohio, 45404

  • GSK Investigational Site

    Dyersburg, Tennessee, 38024

  • GSK Investigational Site

    Englewood, Colorado, 80112

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Glen Burnie, Maryland, 21061

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Gresham, Oregon, 97030

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033-0850

  • GSK Investigational Site

    Hoffman Estates, Illinois, 60195

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Knoxville, Tennessee, 37922

  • GSK Investigational Site

    Lakewood, Colorado, 80401

  • GSK Investigational Site

    Lilburn, Georgia, 30047

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Metairie, Louisiana, 70001

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Murray, Utah, 84107

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Palmdale, California, 93551

  • GSK Investigational Site

    Papillion, Nebraska, 68046

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19135

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    Richmond, Virginia, 23298

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    Skillman, New Jersey, 08558

  • GSK Investigational Site

    Summit, New Jersey, 07901

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Torrance, California, 90503

  • GSK Investigational Site

    Utica, New York, 13502

  • GSK Investigational Site

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.

Being tested
Fluticasone propionate/salmeterol, Fluticasone Propionate
Keywords
asthma, bronchospasm
Medical subject headings
Bronchial Spasm, Motor Activity, Asthma, Exercise-Induced, Asthma

What participants receive

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

  • Fluticasone propionate/salmeterolDrug

    Fluticasone propionate/salmeterol

  • Fluticasone PropionateDrug

    Fluticasone Propionate

Study groups in NCT00118716
Study groupRoleWhat they receive
FSC 100/50 mcg BIDExperimentalParticipants received FSC 100/50 microgram (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days
Receives: Drug: Fluticasone propionate/salmeterol
FP 100 mcg BIDExperimentalParticipants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Receives: Drug: Fluticasone Propionate

What is being measured

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

  1. Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Maximal percent change in FEV1 following exercise challenge was defined as the percent change from pre-exercise baseline FEV1 to the minimum FEV1 collected within one hour following exercise challenge. Maximal percent change in FEV1 following exercise challenge was mean maximal percent change from pre-exercise baseline compared between treatment groups at Treatment Week 4. FEV1 was measured 5, 10, 15, 30, and 60 minutes post-exercise. The minimum FEV1 measured across these time points, regardless of any missing time points, will be used for the calculation of maximal percent change.

    Measured: Baseline and Week 4

Secondary outcomes (6)

  1. Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1

    FEV1 AUC is mean AUC compared between treatment groups at Treatment Day 1. Baseline was defined as the pre-dose FEV1 measure from treatment Day 1. FEV1 AUC was calculated as the area of a trapezoid (calculated as the sum of the bases (top + bottom) divided by 2, then multiplied by width) above the baseline FEV1 area. For participants not completing a serial FEV1 measurement, the last observed post-dose FEV1 measurement was carried forward.

    Measured: Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1

  2. Change From Baseline in Morning Peak Expiratory Flow (AM PEF)

    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the morning. Change from baseline was calculated as the endpoint value minus the baseline value. For AM PEF, baseline was defined as the average of the AM PEF values recorded on the day of Visit 2 (7-14 [+ or -4] days after Visit1) plus the 6 preceding days since AM PEF was measured in the morning.

    Measured: Baseline and Up to Week 4

  3. Change From Baseline in Evening (PM) PEF

    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication after the symptom measurement and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the evening. Change from baseline was calculated as the endpoint value minus the baseline value. Baseline was defined as the average of the values from the 7 days preceding Visit 2 (7-14 [+ or -4] days after Visit1) since these measures were derived from data collected in the evening.

    Measured: Baseline and up to Week 4

  4. Percent of Rescue-free Days

    A rescue-free day was defined as a day when no supplemental albuterol was taken (i.e., 0 puffs recorded for both AM and PM assessments of albuterol use in the daily diary). Percent of rescue-free days was calculated as the number of rescue-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.

    Measured: Up to Week 4

  5. Percent of Symptom-free Days

    A symptom-free day was defined as a day with no symptoms (i.e., a score of 0, indicating no asthma symptoms during the day or previous night, recorded in the daily diary). Percent of symptom-free days was calculated as the number of symptom-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.

    Measured: Up to Week 4

  6. Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ)

    PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Participants responded to each question on a 7-point scale (7= not bothered at all and 1= extremely bothered). The overall PAQLQ score is the mean of all 23 responses (minimum score 1= 5+8+10/23 and maximum score 7= 35+56+70/23) and the individual domain scores are the means of the items in those domains (minimum: 5/5, 8/8, 10/10 and maximum: 35/5, 56/8, 70/10). Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Endpoint was defined from the last questionnaire collected during the double-blind treatment period or discontinuation visit (up to Week 4).

    Measured: Baseline (Week 0) and up to Week 4

Timeline

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

  1. First posted12 Jul 2005 (estimated)
  2. Study start23 Dec 2003
  3. Primary completion1 Apr 2006
  4. Study completion23 Apr 2006

Resources

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
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118716
Sponsor's protocol ID
SFA100314
Status last verified
Dec 2017
First submitted
1 Jul 2005
Last updated
5 Feb 2019
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

  • Pearlman D, Qaqundah P, Matz J, Yancey SW, Stempel DA, Ortega HG. Fluticasone propionate/salmeterol and exercise-induced asthma in children with persistent asthma. Pediatr Pulmonol. 2009 May;44(5):429-35. doi: 10.1002/ppul.20962.

    PubMed 19382218

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone propionate/salmeterol and Fluticasone Propionate in people with Bronchospasm and Activity/Exercise Induced Bronchospasm, run by GlaxoSmithKline at 50 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 3 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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 5 Feb 2019). 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?

Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4 (time frame: Baseline and Week 4). 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 NCT00118716, 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 5 Feb 2019.

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