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lack of data
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This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/salmeterol | Drug | comparator |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4 | The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed. | Days 1 through 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4 | PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed. | Days 1 through 4 |
| Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4 |
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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 | Charlottesville | Virginia | 22908 | United States |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| HZA109895 | 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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Eligible subjects were randomized to one of two sputum induction groups (sputum induction, no sputum induction) and then stratified at a second randomization to one of three treatment groups (Fluticasone Propionate/Salmeterol [FSC 250/50] mcg twice a day [BID], Fluticasone Propionate [FP] 250 mcg BID, or Placebo BID).
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| ID | Title | Description |
|---|---|---|
| FG000 | FSC 250/50 mcg BID | Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily |
| FG001 | FP 250 mcg BID | Fluticasone Propionate (FP) (250 microgram) twice daily |
| FG002 | Placebo Diskus BID | Placebo twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FSC 250/50 mcg BID | Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily |
| BG001 | FP 250 mcg BID | Fluticasone Propionate (FP) (250 microgram) twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4 | The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed. | Posted | Days 1 through 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FSC 250/50 mcg BID | Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heartburn | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Due to the small sample size, efficacy measures were not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| fluticasone propionate | Drug | Comparator |
|
| placebo | Drug | Placebo |
|
FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed. |
| Days 1 through 4 |
| Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4 | eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed. | Days 1 through 4 |
For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109895 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109895 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109895 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109895 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109895 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Physician Decision |
|
| BG002 | Placebo Diskus BID | Placebo twice daily |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 | Placebo Diskus BID | Placebo twice daily |
|
| Secondary | Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4 | PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed. | Posted | Days 1 through 4 |
|
|
| Secondary | Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4 | FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed. | Posted | Days 1 through 4 |
|
|
| Secondary | Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4 | eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed. | Posted | Days 1 through 4 |
|
|
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | FP 250 mcg BID | Fluticasone Propionate (FP) (250 microgram) twice daily | 0 | 5 | 1 | 5 |
| EG002 | Placebo Diskus BID | Placebo twice daily | 0 | 6 | 0 | 6 |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | 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.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| 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 |