A Phase 4 interventional study of Fluticasone propionate/salmeterol and Fluticasone Propionate in Bronchospasm and Activity/Exercise Induced Bronchospasm, sponsored by GlaxoSmithKline. Completed at 50 sites in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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.
44 studies on the registry are indexed under Bronchial Spasm; 4 are open to participants now.
This study's enrollment of 248 is above the median of 70 across 29 interventional studies indexed under Bronchial Spasm.
Browse Bronchial Spasm studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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
Drug: Fluticasone propionate/salmeterol
Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Drug: Fluticasone Propionate
Drug pages: Fluticasone · Salmeterol Xinafoate
Fluticasone propionate/salmeterol
Fluticasone Propionate
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.
Time frame: Baseline and Week 4
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.
Time frame: Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1
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.
Time frame: Baseline and Up to Week 4
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.
Time frame: Baseline and up to Week 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.
Time frame: Up to Week 4
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.
Time frame: Up to Week 4
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).
Time frame: Baseline (Week 0) and up to Week 4
The study was conducted from 23 December 2003 to 23 April 2006 across 51 sites in the United States (US) and a total of 248 participants were randomized.
| Milestone | FSC 100/50 mcg BID | FP 100 mcg BID |
|---|---|---|
| Started | 124 | 124 |
| Completed | 111 | 102 |
| Not completed | 13 | 22 |
| Withdrew: Adverse event | 2 | 7 |
| Withdrew: Protocol violation | 5 | 4 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Exacerbation | 2 | 2 |
| Withdrew: Discontinued by sponsor | 1 | 1 |
| Withdrew: Non-compliance | 1 | 3 |
| Withdrew: Misrandomized | 1 | 1 |
| Withdrew: Expired drug use | 1 | 2 |
| Withdrew: Investigator discretion | 0 | 1 |
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.
| Percent change | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4 | -9.5 ± 0.83 | -12.7 ± 1.06 |
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.
| Liters*hour | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1 | 0.70 ± 0.067 | 0.30 ± 0.059 |
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.
| Liters/minute (L/min) | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| Change From Baseline in Morning Peak Expiratory Flow (AM PEF) | 16.3 ± 2.99 | 9.1 ± 3.86 |
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.
| L/min | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| Change From Baseline in Evening (PM) PEF | 10.8 ± 2.96 | 7.6 ± 3.03 |
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.
| Percentage of days | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| Percent of Rescue-free Days | 59.4 ± 3.21 | 54.7 ± 3.40 |
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.
| Percentage of days | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| Percent of Symptom-free Days | 27.3 ± 3.10 | 28.6 ± 3.04 |
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).
| Scores on a scale | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| Activity limitation week 2 | 0.78 ± 0.092 | 0.63 ± 0.100 |
| Activity limitation week 4 | 0.93 ± 0.113 | 0.75 ± 0.116 |
| Activity limitation endpoint | 0.89 ± 0.104 | 0.67 ± 0.105 |
| Emotional function Week 2 | 0.44 ± 0.066 | 0.48 ± 0.089 |
| Emotional function Week 4 | 0.56 ± 0.096 | 0.47 ± 0.097 |
| Emotional function endpoint | 0.53 ± 0.090 | 0.42 ± 0.088 |
| Symptoms Week 2 | 0.39 ± 0.085 | 0.49 ± 0.081 |
| Symptoms Week 4 | 0.52 ± 0.101 | 0.55 ± 0.109 |
| Symptoms Endpoint | 0.48 ± 0.094 | 0.51 ± 0.101 |
| Overall score Week 2 | 0.49 ± 0.068 | 0.52 ± 0.074 |
| Overall score Week 4 | 0.62 ± 0.091 | 0.57 ± 0.092 |
| Overall score Endpoint | 0.59 ± 0.084 | 0.51 ± 0.084 |
Collected over Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FSC 100/50mcg BID | 0/124 (0%) | 0/124 (0%) | 37/124 (29.8%) |
| FP 100mcg BID | 0/124 (0%) | 0/124 (0%) | 35/124 (28.2%) |
| Event | FSC 100/50mcg BID | FP 100mcg BID |
|---|---|---|
| HeadacheNervous system disorders | 4/124 | 6/124 |
| Upper respiratory tract infectionInfections and infestations | 4/124 | 2/124 |
| UrticariaSkin and subcutaneous tissue disorders | 0/124 | 4/124 |
| Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders | 3/124 | 1/124 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 0/124 | 3/124 |
| Abdominal pain upperGastrointestinal disorders | 3/124 | 2/124 |
| NasopharyngitisInfections and infestations | 2/124 | 1/124 |
| BronchitisInfections and infestations | 0/124 | 2/124 |
| GastroenteritisInfections and infestations | 2/124 | 0/124 |
| Viral upper respiratory tract infectionInfections and infestations | 0/124 | 2/124 |
| Age, Continuous(Years) | FSC 100/50mcg BID | FP 100mcg BID | Total |
|---|---|---|---|
| Mean | 11.1 ± 3.33 | 11.0 ± 3.57 | 11.1 ± 3.45 |
| Sex: Female, Male(Participants) | FSC 100/50mcg BID | FP 100mcg BID | Total |
|---|---|---|---|
| Female | 49 | 50 | 99 |
| Male | 75 | 74 | 149 |
| Race/Ethnicity, Customized(Participants) | FSC 100/50mcg BID | FP 100mcg BID | Total |
|---|---|---|---|
| American Hispanic | 12 | 8 | 20 |
| Arabic/North African | 2 | 1 | 3 |
| Black | 26 | 29 | 55 |
| East & South East Asian | 0 | 2 | 2 |
| Japanese | 1 | 0 | 1 |
| South Asian | 1 | 1 | 2 |
| White/Caucasian | 81 | 81 | 162 |
| Other | 1 | 2 | 3 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Ran from Dec 2003 to primary completion in Apr 2006, 27 months.
Results were first posted in Feb 2019, 12 years 10 months after primary completion.
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Studies of the drugs tested here: Fluticasone · Salmeterol Xinafoate