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The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen attribute rating items followed by fourteen importance weighing questions. The Preference Module includes the same items along with preference questions related to each item as well as a global preference question.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone dipropionate | Drug | Beclomethasone dipropionate | ||
| Flunisolide | Drug | Flunisolide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores | EARNS-Q Preference Module consists of efficacy, sensory perception (SP), device characteristic (DC), spray delivery (SD), overall product preference (OPP) and total domain. TSQM consists of global satisfaction (GS), convenience, effectiveness and side-effects (SE) domains. Positive (+ve) correlation of EARNS-Q preference scores with change on TSQM domains indicate that preference for a product is associated with better TSQM scores. Negative (-ve) correlation with mean daily rTNSS indicate that preference for a product is associated with lower mean daily rTNSS. Change in TSQM domain scores and mean daily rTNSS was calculated as scores in Treatment Period (TP) 2 minus scores in TP1; change in TSQM is +ve, product in TP2 is preferred, vice-versa; change in rTNSS is -ve, product administered in TP2 is preferred, vice-versa. | Day 1 to Day 23 |
| Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores | The 28 items of the EARNS-Q experience module assess 14 attributes with regard to their product rating and their importance of efficacy, SP, DC and SD. The EARNS-Q preference module consists of additional 15 items that evaluate preference by comparing two products based on the same 14 experience attributes as well as on OPP. Change in EARNS-Q Experience Module domain scores was calculated as scores in TP2 minus scores in TP1. If the change in EARNS-Q Experience Module domain scores is +ve, product in TP2 is preferred and vice-versa. A higher product rating for one of the sprays lead to a preference for that spray. The EARNS-Q preference module was assessed only once, at the end of TP2. Positive correlations indicate agreement (i.e. preference for a product is positively associated with better experience with same product). | Day 1 to Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean rTNSS Over Period | The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a 4 point scale ranging from 0 to 3. Each individual symptom was evaluated using a scale of 0 (none; symptom is not present), 1 (mild; sign/symptom clearly present but minimal awareness; easily tolerated), 2 (moderate; definite awareness of sign/symptom that is bothersome but tolerable), or 3 (severe; sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The rTNSS ranges from 0 (none) to 12 (severe). Higher score represents greater severity of symptoms. The reflective assessment of the TNSS scores the four nasal symptoms over the previous 12 hours and are assessed in the morning and evening. The participants themselves scored nasal symptoms in a diary card. The analysis was done based on the rTNSS averaged over the two weeks of the treatment period. |
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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 | Fresno | California | 93720 | 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 |
|---|---|---|---|
| FFR105693 | Annotated Case Report Form | 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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A total of 97 participants were randomized for the study in a crossover manner in a ratio of 1:1 to one of two blinded treatment groups of 116 microgram (µg) Nasarel or 168 µg Beconase AQ® metered dose nasal spray to be administered twice daily for 1 week. The study consisted of 2 treatment periods of 1 week each and 1 washout period of 7 days.
The study was planned on 90 participants, male or female aged 18 years or older, diagnosed with seasonal allergic rhinitis (SAR) across 8 investigational sites in the United States (US) from 01 May 2006 to 29 June 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Beconase Then Nasarel | Participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week. After a washout period of 7 days, participants were administered 116 µg Nasarel, metered dose nasal spray twice daily for 1 week. |
| FG001 | Nasarel Then Beconase |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Intervention Period 1 |
|
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| Day 1 to 8 of each treatment period |
| Number or Participants With Preference of Nasal Sprays (Nasarel or Beconase AQ) at the End of the Last Cross-over Period Using the Preference Module of the EARNS-Q | The participants with preference of nasal sprays (Nasarel or Beconase AQ) at the end of the last cross-over period was planned to be analyzed using the preference module of the EARNS-Q. The data for this outcome measure was not collected and the result summary was not generated. | Up to Day 23 |
| Napa |
| California |
| 94558 |
| United States |
| GSK Investigational Site | Roseville | California | 95678 | United States |
| GSK Investigational Site | San Francisco | California | 94102 | United States |
| GSK Investigational Site | San Jose | California | 95117 | United States |
| GSK Investigational Site | San Jose | California | 95128 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR105693 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR105693 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR105693 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR105693 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR105693 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR105693 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week. After a washout period of 7 days, participants were administered 168 µg Beconase AQ, metered dose nasal spray twice daily for 1 week. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2: Washout Period (7 Days) |
|
| Period 3: Intervention Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Beconase + Nasarel | Participants were administered 168 µg Beconase AQ or 116 µg Nasarel metered dose nasal spray twice daily for 1 week in a sequence of Beconase /Nasarel or Nasarel/Beconase according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. |
| 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 (NIH/OMB) | 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 | Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores | EARNS-Q Preference Module consists of efficacy, sensory perception (SP), device characteristic (DC), spray delivery (SD), overall product preference (OPP) and total domain. TSQM consists of global satisfaction (GS), convenience, effectiveness and side-effects (SE) domains. Positive (+ve) correlation of EARNS-Q preference scores with change on TSQM domains indicate that preference for a product is associated with better TSQM scores. Negative (-ve) correlation with mean daily rTNSS indicate that preference for a product is associated with lower mean daily rTNSS. Change in TSQM domain scores and mean daily rTNSS was calculated as scores in Treatment Period (TP) 2 minus scores in TP1; change in TSQM is +ve, product in TP2 is preferred, vice-versa; change in rTNSS is -ve, product administered in TP2 is preferred, vice-versa. | Intent- to- Treat (ITT) Population was defined as all the participants who were randomized to the study drug. Pearson correlations was used in correlational analyses. | Posted | Number | correlation coefficient | Day 1 to Day 23 |
|
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| ||||||||||||||||||||||||||||||||||||
| Primary | Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores | The 28 items of the EARNS-Q experience module assess 14 attributes with regard to their product rating and their importance of efficacy, SP, DC and SD. The EARNS-Q preference module consists of additional 15 items that evaluate preference by comparing two products based on the same 14 experience attributes as well as on OPP. Change in EARNS-Q Experience Module domain scores was calculated as scores in TP2 minus scores in TP1. If the change in EARNS-Q Experience Module domain scores is +ve, product in TP2 is preferred and vice-versa. A higher product rating for one of the sprays lead to a preference for that spray. The EARNS-Q preference module was assessed only once, at the end of TP2. Positive correlations indicate agreement (i.e. preference for a product is positively associated with better experience with same product). | ITT Population. Pearson correlations was used in correlational analyses. | Posted | Number | correlation coefficient | Day 1 to Day 23 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Mean rTNSS Over Period | The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a 4 point scale ranging from 0 to 3. Each individual symptom was evaluated using a scale of 0 (none; symptom is not present), 1 (mild; sign/symptom clearly present but minimal awareness; easily tolerated), 2 (moderate; definite awareness of sign/symptom that is bothersome but tolerable), or 3 (severe; sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The rTNSS ranges from 0 (none) to 12 (severe). Higher score represents greater severity of symptoms. The reflective assessment of the TNSS scores the four nasal symptoms over the previous 12 hours and are assessed in the morning and evening. The participants themselves scored nasal symptoms in a diary card. The analysis was done based on the rTNSS averaged over the two weeks of the treatment period. | Efficacy population was defined as all participants who completed both treatment periods, who had efficacy and questionnaire data recorded in both treatment periods, and who had recorded sufficient efficacy data to calculate daily rTNSS. | Posted | Least Squares Mean | Standard Error | Score on scale | Day 1 to 8 of each treatment period |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number or Participants With Preference of Nasal Sprays (Nasarel or Beconase AQ) at the End of the Last Cross-over Period Using the Preference Module of the EARNS-Q | The participants with preference of nasal sprays (Nasarel or Beconase AQ) at the end of the last cross-over period was planned to be analyzed using the preference module of the EARNS-Q. The data for this outcome measure was not collected and the result summary was not generated. | Efficacy Population. No participants were analyzed for this outcome measure. | Posted | Up to Day 23 |
|
|
Post randomization (Day 1) up to 23 days
ITT Population was used for analysis.
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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 | Beconase | In each period of the study, participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. | 0 | 97 | 0 | 97 | 16 | 97 |
| EG001 | Nasarel | In each period of the study, participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. | 0 | 97 | 0 | 97 | 17 | 97 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hangover | General disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| C007734 | flunisolide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| EARNS-Q Total-TSQM SE |
|
| EARNS-Q Total-Mean rTNSS |
|
| EARNS-Q Efficacy-TSQM GS |
|
| EARNS-Q Efficacy -TSQM Convenience |
|
| EARNS-Q Efficacy-TSQM Effectiveness |
|
| EARNS-Q Efficacy -TSQM SE |
|
| EARNS-Q Efficacy-Mean rTNSS |
|
| EARNS-Q SP-TSQM GS |
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| EARNS-Q SP-TSQM Convenience |
|
| EARNS-Q SP-TSQM Effectiveness |
|
| EARNS-Q SP-TSQM SE |
|
| EARNS-Q SP-Mean rTNSS |
|
| EARNS-Q DC-TSQM GS |
|
| EARNS-Q DC-TSQM Convenience |
|
| EARNS-Q DC-TSQM Effectiveness |
|
| EARNS-Q DC-TSQM SE |
|
| EARNS-Q DC-Mean rTNSS |
|
| EARNS-Q SD-TSQM GS |
|
| EARNS-Q SD-TSQM Convenience |
|
| EARNS-Q SD-TSQM Effectiveness |
|
| EARNS-Q SD-TSQM SE |
|
| EARNS-Q SD-Mean rTNSS |
|
| EARNS-Q OPP-TSQM GS |
|
| EARNS-Q OPP-TSQM Convenience |
|
| EARNS-Q OPP-TSQM Effectiveness |
|
| EARNS-Q OPP-TSQM SE |
|
| EARNS-Q OPP-Mean rTNSS |
|
|
|
| Nasarel |
In each period of the study, participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. |
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