Phase 4
N=377
Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS
Rhinitis, Allergic, Perennial
Bottom Line
View on ClinicalTrials.gov: NCT00539006 ↗Enrolled (actual)
377
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcome: Primary: Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos — -2.7; -1.5; -2.4; -1.6 Scores on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FPNS (Drug); FFNS (Drug); placebo FPNS (Drug); placebo FFNS (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos |
-2.7; -1.5; -2.4; -1.6; -2.5; -1.9 | <0.001 sig |
| PRIMARY Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor |
43; 41; 84; 21; 17; 38 | <0.001 sig |
| SECONDARY Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat |
43; 46; 89; 15; 17; 32 | — |
| SECONDARY Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use |
19; 28; 47; 42; 37; 79 | — |
| SECONDARY Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist |
37; 49; 86; 17; 14; 31 | — |
| SECONDARY Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos |
-2.8; -1.6; -2.6; -1.7; -2.6; -2.0 | — |
| SECONDARY Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos |
-2.5; -1.3; -2.4; -1.6; -2.4; -1.9 | — |
Summary
The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.
Eligibility Criteria
Inclusion Criteria
- Informed consent
- Subject has provided an appropriately signed and dated informed consent.
- Otherwise healthy outpatient with fall allergy
- Subject is treatable on an outpatient basis.
- Age
- 18 years or age or older at time of Visit 2
- Male or eligible female
- Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be required of all females at all visits to determine if the subject is pregnant.
- To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
- Abstinence
- Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
- Oral contraceptive (either combined estrogen/progestin or progestin only)
- Injectable progestogen
- Implants of levonorgestrel
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
- Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject
- Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide
- Estrogenic vaginal ring
- Diagnosis of SAR
- SAR is defined as follows:
- A clinical history (written or verbal) of SAR with seasonal allergy symptoms (nasal symptoms) during each of the last two fall allergy seasons, and
- A positive skin test (by prick method) to fall allergen prevalent to the geographic area during the conduct of the study, within 12 months prior to Visit 1 or at Visit 1.
- A positive skin test is defined as a wheal 3 mm larger than the diluent control for prick testing.
- In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed as a diagnosis of SAR.
- Subjects who meet the above criteria and who may also have perennial allergic rhinitis or vasomotor rhinitis are eligible for randomization.
- Adequate exposure to seasonal pollen
- Subject resides within a geographical region where exposure to fall seasonal allergen is expected to be significant during the entire study period.
- Subject does not plan to travel outside this area for more than 48 hours of the study period.
- Ability to comply with study procedures
- Subject understands and is willing, able and likely to comply with study procedures and restrictions.
- Literate
- Subject must be able to read, comprehend, and record information in English
Exclusion Criteria
- Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST).
- Significant concomitant medical conditions, defined as but not limited to:
- A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
- A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug
- Nasal (eg, nasal septum) injury or surgery in the last 3 months
- Asthma, with the exception of mild intermittent asthma [National Asthma Education and Prevention Program (NARPP) Guidelines, 2002].
- Rhinitis medicamentosa
- Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening per
Data sourced from ClinicalTrials.gov (NCT00539006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.