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Flunisolide

Phase 3

Rhinitis, Allergic, Perennial | Small molecule | Respiratory |GSK plc|Last Updated: Jan 16, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

Clinical trial landscape

Flunisolide · 1 trial · 1 indication

Phase 3 1
NCT00346775Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)Rhinitis, Allergic, Perennial
COMPLETED97 Analytics
PHASE3COMPLETED
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
Rhinitis, Allergic, PerennialUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Day 1 to Day 23

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.

Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores
Day 1 to Day 23

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).

Secondary Endpoints

Mean rTNSS Over Period
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
Up to Day 23
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Beclomethasone dipropionateDRUGBeclomethasone dipropionate
FlunisolideDRUGFlunisolide
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: * Seasonal allergic rhinitis. * Nasal allergy symptoms during the spring allergy season. Exclusion Criteria: * Prior use of beclomethasone dipropionate or flunisolide. * Significant concomitant medical conditions. * Use of corticosteroids. * Use of allergy and other identified...

Countries:United States
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Frequently asked questions about Flunisolide

What is Flunisolide used for?

Flunisolide is used for perennial allergic rhinitis, a condition involving year-round nasal allergy symptoms. It is a small molecule respiratory drug being developed by GSK plc. The drug is currently in Phase 3 clinical development, though it remains investigational and has not been approved for this use.

Who makes Flunisolide?

Flunisolide is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 3 clinical development for perennial allergic rhinitis, a respiratory condition. GSK is conducting trials to evaluate the drug's effects in patients with this condition.

What phase is Flunisolide in?

Flunisolide is in Phase 3 clinical development. It is being studied for the treatment of perennial allergic rhinitis, a respiratory condition. The drug is investigational and not yet approved, as it is still undergoing clinical trials to assess its safety and efficacy in patients.

What clinical trials is Flunisolide in?

Flunisolide has one completed Phase 3 clinical trial with the identifier NCT00346775. This trial, titled 'Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)', enrolled 97 participants in the United States. The study focused on patients with perennial allergic rhinitis and was not blinded or controlled.

Is Flunisolide FDA approved?

Flunisolide is not FDA approved for perennial allergic rhinitis. It is currently in Phase 3 clinical development, meaning it is still being studied in clinical trials. The drug has completed one Phase 3 trial, but approval status has not been established, and it remains an investigational product.