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The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.
A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: FP, SFC, Placebo | Experimental | Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period |
|
| Sequence 2: Placebo, SFC, FP | Experimental | Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period |
|
| Sequence 3: SFC, FP, Placebo | Experimental | Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period |
|
| Sequence 4: SFC, Placebo, FP | Experimental | Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period |
|
| Sequence 5: FP, Placebo, SFC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP | Drug | Fluticasone Propionate 100 mcg BD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35 | Number of peripheral blood eosinophils measured from blood draws | 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14 | Number of peripheral blood eosinophils measured from blood draws | 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14 |
| Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35 |
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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 | Madison | Wisconsin | 53792 | United States | ||
| GSK Investigational Site |
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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 |
|---|---|---|---|
| HZA109912 | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: FP, SFC, Placebo | Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period |
| FG001 | Sequence 2: Placebo, SFC, FP | Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period |
| FG002 | Sequence 3: SFC, FP, Placebo | Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period |
| FG003 | Sequence 4: SFC, Placebo, FP | Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period |
| FG004 | Sequence 5: FP, Placebo, SFC | Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period |
| FG005 | Sequence 6: Placebo, FP, SFC | Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Period |
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| Second Treatment Period |
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| Third Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | Overall Study Population: participants in all three treatment periods |
| 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 | Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35 | Number of peripheral blood eosinophils measured from blood draws | Intent-to-Treat (ITT) Population: All participants receiving at least one dose of study medication who had at least one post-randomization efficacy assessment | Posted | Mean | 95% Confidence Interval | Giga Units per Liter (GI/L) | 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 |
|
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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 | Placebo | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| 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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| Experimental |
Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period |
|
| Sequence 6: Placebo, FP, SFC | Experimental | Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period |
|
| SFC | Drug | Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD |
|
| Placebo | Drug | Matching Placebo |
|
Amount of serum interleukin (IL)-5 measured from blood draws |
| 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 |
| Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14 | Amount of serum IL-5 measured from blood draws | 0-6 hours post allergen challenge, 1 hour after dosing, Day 14 |
| Manchester |
| M23 9QZ |
| United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109912 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109912 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109912 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109912 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109912 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA109912 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 |
| SFC 50/100 mcg BID |
Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID |
|
|
| Secondary | Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14 | Number of peripheral blood eosinophils measured from blood draws | ITT Population | Posted | Mean | 95% Confidence Interval | Giga Units per Liter (GI/L) | 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14 |
|
|
|
| Secondary | Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35 | Amount of serum interleukin (IL)-5 measured from blood draws | Not Posted | 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 | Participants |
| Secondary | Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14 | Amount of serum IL-5 measured from blood draws | Not Posted | 0-6 hours post allergen challenge, 1 hour after dosing, Day 14 | Participants |
| 0 |
| 22 |
| 14 |
| 22 |
| EG001 | FP 100 mcg BID | Fluticasone Propionate 100 mcg BID | 0 | 23 | 16 | 23 |
| EG002 | SFC 50/100 BID | Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID | 1 | 22 | 10 | 22 |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngolarngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| House dust allergy | Immune system disorders | MedDRA | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | 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 |