Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis (SISRIP)
|Study Design:||Time Perspective: Prospective|
|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|
- Comparison symptoms´ score between initial score day 1 (V-0) vs. day 28 ± 2 (V-1). With a 7-point Likert scale. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]The main outcome will be the described symptoms´ score and will be analyzed by comparison of the initial symptom score day 1 (V-0) vs. day 30 ± 2 (V-1). This is a quasi quantitative variable with a 7-point Likert scale.
|Study Start Date:||August 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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.
Symptoms relief of intermittent or persistent rhinitis .
Safety profile (MedDRA adverse events), tolerability and treatment compliance.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369563
|Naucalpan de Juarez, Estado de Mexico, Mexico, 53519|
|Principal Investigator:||Francisco J Saynes, MD||Private clinical atention|
|Principal Investigator:||Francisco Saynes, MD||Private clinical Atention|