Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis
Condition: Perennial Rhinitis; Seasonal Rhinitis
MeSH terms: Rhinitis
Study type: Observational

Summary: 
      To assess the efficacy, safety and tolerability of ciclesonide 200 mcg once daily, applied as
      a nasal spray for four weeks. The main outcome will be the improvement on global and
      individual typical and associated symptoms of intermittent or persistent rhinitis.
    

Detailed description: 
      Study design:

      This is a prospective national wide Non- Interventional study. Patients number 2400 CRFs will
      be distributed in order to obtain a ITT (Intention to Treat) sample of 1800 (75%) patients,
      and PP (Per Protocol) sample of 1100 patients (60%).

      400 patients will be applied to "prick test" and the results will be analyzed to determine
      the prevalence and response to treatment according to the diagnosis of allergic rhinitis.

      Eligible population Male or female external patients over 18 years and under 50 years with
      active rhinitis (anterior or posterior rhinorrhea, sneezing, nasal congestion and itching)
      persistent (≥ 4 days a week for 4 consecutive weeks) or intermittent (< 4 days a week for ≤ 4
      consecutive weeks), with medical history of rhinitis 2 years prior to their participation in
      this study and whose nasal symptoms have been severe enough to require continuous or
      intermittent treatment (it requires a patient's symptoms need treatment at least for a 4
      weeks period). All patients have to sign the informed consent or give verbal confirmation
      prior to their inclusion in the study.

      Evaluation criteria:

      Primary:

      Symptoms relief of intermittent or persistent rhinitis .

      Secondary:

      Safety profile (MedDRA adverse events), tolerability and treatment compliance.

      Collective evaluation:

      The PP population will be considered for confirmatory analysis. The key variable "symptom
      relief" will be assessed for the Intent-to-treat population or ITT for comparison.

      Statistical analysis:

      The investigators will perform descriptive analysis of demographic data and scores of
      symptoms severity of intermittent or persistent rhinitis (ie, nasal congestion, anterior or
      posterior rhinorrhea, sneezing and nasal itching). All results will be expressed as mean
      values standard deviation, or percentages in case of categorical variables. Symptoms
      improvement will be assessed using symptom severity scores registered (by physicians and
      patients) at the initial visit versus those recorded at the final visit. The contrast between
      means will be adjusted by recruitment centers (random factor), physicians' specialty (random
      factor), and demographic variables such as age, sex, body mass index (fixed factors in case
      of categories or covariates in case of continuous variables).

      The frequency of adverse events will be recorded and in case of an important finding the
      investigators will search for risk factors using a nested sample from the same population and
      matched by age and sex.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male or female external patients over 18 years and under 50 years with active rhinitis
        (anterior or posterior rhinorrhea, sneezing, nasal congestion and itching) persistent (≥ 4
        days a week for 4 consecutive weeks) or intermittent (<4 days a week for ≤ 4 consecutive
        weeks), with medical history of rhinitis 2 years prior to their participation in this study
        and whose nasal symptoms have been severe enough to require continuous or intermittent
        treatment (it requires a patient's symptoms need treatment at least for a 4 weeks period).
        All patients have to sign the informed consent or give verbal confirmation prior to their
        inclusion in the study.
      
Keywords: rhinitis; ciclesonide; intermittent rhinitis; persistent rhinitis