Persistent allergic rhinitis
Conditions
Interventions
Product Name: Triamcinolone Acetonide Nasal Spray
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: triamcinolone acetonide
CAS Number: [76-25-5]
Concentration unit: µg microgram(s)
Co
Sponsors
Neolab Limited
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. Willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD) (women of childbearing potential only). 6. 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 Triamcinolone Acetonide 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 patient 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(1), in addition to a positive skin prick test to grass pollen. 8. Patients who have previously been enrolled into this study. 9. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit. 10. Patients who are scheduled to receive any other investigational drug during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether or not a new formulation of Triamcinolone Acetonide (TA) 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). ;Secondary Objective: Secondary objectives include assessments of peak nasal inspiratory flow rate, systemic effects (overnight urinary cortisol/creatinine ratio), total nasal symptoms scores, and adverse events.;Primary end point(s): The primary efficacy variable is the Juniper mini rhinitis quality of life (MiniRQLQ) score. | — |
Countries
United Kingdom
Outcome results
None listed