Persistent allergic rhinitis
Conditions
Interventions
Product Name: Fluticasone Propionate Aqueous Nasal Spray
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: Fluticasone Propionate
CAS Nu
Sponsors
Neolab td
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Male or female between 18 and 70 years of age inclusive. 3. Diagnosis of persistent allergic rhinitis. 4. Skin-prick positive to at least one common aeroallergen. 5. Score on miniRQLQ of =1 following a 2 week run-in period. 6. Willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD) (women of childbearing potential only). 7. In the opinion of the investigator, able to comply with the requirements of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP). 2. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study. 3. Nasal polyposis (Grade 2+) or significant (=50%) septal deviation. 4. Asthmatic patients receiving doses of inhaled corticosteroids greater than 800µg beclometasone dipropionate or equivalent unless their dose has been stable for at least 28 days 5. Females who are pregnant, lactating or planning to become pregnant. 6. Clinically significant laboratory test results, as judged by the investigator. 7. Patients with seasonal allergic rhinitis classified as severe according to the ARIA Guidelines, in addition to a positive skin prick test to grass pollen. 8. Patients previously enrolled into this study, except those screened and excluded on the grounds of inclusion criteria number 5 prior to amendment 4 (protocol v2), and those that declined randomisation due to visit timing difficulties prior to the same amendment. 9. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening, except where related to previous screening (i.e. placebo run-in) for this study prior to amendment 4 (protocol v2). 10. Patients who are scheduled to receive any other investigational drug during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Assessment of peak nasal inspiratory flow rate, systemic effects (overnight urinary cortisol/creatinine ratio), total nasal symptom scores, and adverse events.;Primary end point(s): The primary efficacy variable is the Juniper mini rhinitis quality of life (MiniRQLQ) score.;Main Objective: To determine whether or not a new formulation of fluticason propionate aqueous nasal spray is non-inferior to the old in terms of efficacy, in patients with persistent allergic rhinitis, using the Juniper mini rhinoconjunctivitis quality of life questionnaire (miniRQLQ). | — |
Countries
United Kingdom
Outcome results
None listed