Rhinocort Aqua Versus Placebo and Fluticasone Propionate

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo; Drug: Budesonide; Drug: Fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641680

D5360C00005

Details and patient eligibility

About

The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

Enrollment: 750 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least a 2 year documented history of seasonal allergic rhinitis

• who, in the opinion of the investigator,

• is a candidate for treatment with nasal steroids based on a history of either

  • a)inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or
  • b) prior successful treatment with nasal steroids.

• A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.

Exclusion criteria

• Primary or secondary adrenal insufficiency
• Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
• A diagnosis of asthma requiring treatment as specifies in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

750 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Budesonide

Treatment:

Drug: Budesonide

2

Active Comparator group

Description:

Fluticasone propionate

Treatment:

Drug: Fluticasone propionate

3

Placebo Comparator group

Treatment:

Drug: Placebo