Perennial Rhinitis Clinical Trial
Official title:
Non-interventional Clinical Trial, to Assess the Efficacy, Safety and Tolerability of Ciclesonide 200 Mcg Once Daily, Applied as a Nasal Spray for Four Weeks, in the Treatment of Intermittent and Persistent Rhinitis
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.
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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01330017 -
Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)
|
Phase 2 |