Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis (SISRIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01369563
First received: June 7, 2011
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition
Perennial Rhinitis
Seasonal Rhinitis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.


Enrollment: 1630
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  1. All patients have to sign the informed consent or give verbal confirmation prior to their inclusion in the study.
  2. Outpatient (external) male or female over 18 years and under 50 years.
  3. Patients 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).
  4. Patient 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).
  5. Patient with the ability to understand the risks and benefits requirement while participating in the study and is able to accomplish the study treatment and with filling questionnaires and patient's diaries.

Exclusion Criteria:

  1. Patient with other nasal disease including: nasal polyps or nasal trauma recent.
  2. Patient with intranasal malformations (cysts and fistulas of the nose dorsum, prenasal space malformation, midline dystrophy, arrhinea, abnormalities of the tear ducts), or other conditions such as; recent nasal biopsy, drug rhinitis.
  3. Non-controlled asthma or who were under systemic corticosteroid treatment.
  4. Patient with Chronic Obstructive Pulmonary Disease.
  5. Medical history of respiratory infection or other disease including bronchitis, pneumonia, common cold, acute or chronic sinusitis, influenza, etc. within 30 days prior to its inclusion in the study.
  6. Patient receiving antibiotic therapy for any acute illness during the past 14 days.
  7. Patient vaccinated against pneumococcus, H1N1 & seasonal influenza (past 30 days).
  8. Patient required initiation or dose escalation immunotherapy. Immunotherapy is permitted if started 90 days ago and the patient received a stable dose during the last 30 days.
  9. Patient has participated in another research study within 30 days preceding this visit.
  10. Patient with medical history of hypersensitivity to steroids or any excipients of this class of drugs.
  11. Treatment with systemic corticosteroids for a chronic or intermittent disorder (e.g., dermatitis) during the last six months or can present a condition that requires them.
  12. Medical history of alcoholism and/or drug abuse in the last 2 years.
  13. Medical history or positive testing for HIV, hepatitis B or C.
  14. The patient uses any of drugs listed in the list on page 5 Table.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369563

Locations
Mexico
Yasmín Crespo
Naucalpan de Juarez, Estado de Mexico, Mexico, 53519
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Francisco J Saynes, MD Private clinical atention
Principal Investigator: Francisco Saynes, MD Private clinical Atention
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01369563     History of Changes
Other Study ID Numbers: MX028, U1111-1133-6326
Study First Received: June 7, 2011
Last Updated: September 14, 2012
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Takeda:
rhinitis
ciclesonide
intermittent rhinitis
persistent rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014