Nasya in Allergic Rhinitis

InQpharm

Status and phase: Completed; Phase 3

Conditions: Allergic Rhinitis

Treatments: Device: Nasya; Device: Saline solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01503957

INQ/023411

Details and patient eligibility

About

The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years
• Written informed consent

Exclusion criteria

• Clinically significant disease that could interfere with the evaluation of study medication
• Participation in other studies within the last 4 weeks / during the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Saline solution

Placebo Comparator group

Description:

Nasal spray

Treatment:

Device: Saline solution

Nasya

Experimental group

Description:

Thixotropic nasal spray suspension

Treatment:

Device: Nasya