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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSC 100/50 mcg BID | Experimental | 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 |
|
| FP 100 mcg BID | Experimental | Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate/salmeterol | Drug | Fluticasone propionate/salmeterol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19382218 | Background | 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. |
| Label | URL |
|---|---|
| http://www.findclinicalstudy.com | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SFA100314 | Individual Participant Data Set | View IPD |
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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Out of 789 participants screened, 389 participants were screen failures and 152 participants were Baseline failures.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FSC 100/50 mcg BID | Participants received Fluticasone Propionate/Salmeterol Combination (FSC) 100/50 micrograms (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days |
| FG001 | FP 100 mcg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Fluticasone Propionate |
| Drug |
Fluticasone Propionate |
|
| 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. | 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. | 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. | 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. | 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). | Baseline (Week 0) and up to Week 4 |
| Huntington Beach |
| California |
| 92647 |
| United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | Palmdale | California | 93551 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | Torrance | California | 90503 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Centennial | Colorado | 80112 | United States |
| GSK Investigational Site | Englewood | Colorado | 80112 | United States |
| GSK Investigational Site | Lakewood | Colorado | 80401 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Lilburn | Georgia | 30047 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Hoffman Estates | Illinois | 60195 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70001 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | Glen Burnie | Maryland | 21061 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Papillion | Nebraska | 68046 | United States |
| GSK Investigational Site | Skillman | New Jersey | 08558 | United States |
| GSK Investigational Site | Summit | New Jersey | 07901 | United States |
| GSK Investigational Site | Commack | New York | 11725 | United States |
| GSK Investigational Site | Utica | New York | 13502 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Dayton | Ohio | 45404 | United States |
| GSK Investigational Site | Gresham | Oregon | 97030 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Portland | Oregon | 97213 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033-0850 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19135 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Dyersburg | Tennessee | 38024 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37922 | United States |
| GSK Investigational Site | Dallas | Texas | 75204 | United States |
| GSK Investigational Site | Houston | Texas | 77074 | United States |
| GSK Investigational Site | Murray | Utah | 84107 | United States |
| GSK Investigational Site | Richmond | Virginia | 23298 | United States |
| GSK Investigational Site | Greenfield | Wisconsin | 53228 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100314 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100314 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100314 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100314 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100314 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants received Fluticasone Propionate (FP) 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FSC 100/50mcg BID | Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days. |
| BG001 | FP 100mcg BID | Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat (ITT) population included all participants randomized to study drug. The number of participants available at that particular time point were used for analysis. | Posted | Mean | Standard Error | Percent change | Baseline and Week 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Here, 'N' denotes participants with data available at the specified time point. | Posted | Mean | Standard Error | Liters*hour | Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Here, 'N' denotes participants with data available at the specified time point. | Posted | Mean | Standard Error | Liters/minute (L/min) | Baseline and Up to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Here, 'N' denotes participants with data available at the specified time point. | Posted | Mean | Standard Error | L/min | Baseline and up to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Here, 'N' denotes participants with data available at the specified time point. | Posted | Mean | Standard Error | Percentage of days | Up to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Here, 'N' denotes participants with data available at the specified time point. | Posted | Mean | Standard Error | Percentage of days | Up to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT Population. The PAQLQ was administered only to participants >=7 years old. | Posted | Mean | Standard Error | Scores on a scale | Baseline (Week 0) and up to Week 4 |
|
Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days)
ITT population was used for the analysis of adverse events and serious adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FSC 100/50mcg BID | Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days. | 0 | 124 | 0 | 124 | 37 | 124 |
| EG001 | FP 100mcg BID | Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days. | 0 | 124 | 0 | 124 | 35 | 124 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Asperger's disorder | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Tongue tie operation | Surgical and medical procedures | MedDRA 9.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001986 | Bronchial Spasm |
| D009043 | Motor Activity |
| D001250 | Asthma, Exercise-Induced |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Arabic/North African |
|
| Black |
|
| East & South East Asian |
|
| Japanese |
|
| South Asian |
|
| White/Caucasian |
|
| Other |
|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
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|
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| Units | Counts |
|---|---|
| Participants |
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