Perennial RhinitisSISRIPNCT01369563
Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis
An observational study of Perennial Rhinitis and Seasonal Rhinitis, run by AstraZeneca at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Perennial Rhinitis, Seasonal Rhinitis
- How many people
- 1,630 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- All patients have to sign the informed consent or give verbal confirmation prior to their inclusion in the study.
- Outpatient (external) male or female over 18 years and under 50 years.
- 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).
- 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).
- 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.
Who cannot join
- Patient with other nasal disease including: nasal polyps or nasal trauma recent.
- 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.
- Non-controlled asthma or who were under systemic corticosteroid treatment.
- Patient with Chronic Obstructive Pulmonary Disease.
- 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.
- Patient receiving antibiotic therapy for any acute illness during the past 14 days.
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- Patient vaccinated against pneumococcus, H1N1 \& seasonal influenza (past 30 days).
- 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.
- Patient has participated in another research study within 30 days preceding this visit.
- Patient with medical history of hypersensitivity to steroids or any excipients of this class of drugs.
- 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.
- Medical history of alcoholism and/or drug abuse in the last 2 years.
- Medical history or positive testing for HIV, hepatitis B or C.
- The patient uses any of drugs listed in the list on page 5 Table.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Perennial Rhinitis, Seasonal Rhinitis
- Keywords
- rhinitis, ciclesonide, intermittent rhinitis, persistent rhinitis
- Medical subject headings
- Rhinitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison symptoms´ score between initial score day 1 (V-0) vs. day 28 ± 2 (V-1). With a 7-point Likert scale.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial RhinitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369563
- Sponsor's protocol ID
- MX028
- Other IDs
- U1111-1133-6326
- Acronym
- SISRIP
- Status last verified
- Sep 2016
- First submitted
- 7 Jun 2011
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01369563
- Acronym / sponsor ID
- SISRIP / MX028
- Conditions
- Perennial Rhinitis, Seasonal Rhinitis
- Keywords
- rhinitis, ciclesonide, intermittent rhinitis, persistent rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,630 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- All patients have to sign the informed consent or give verbal confirmation prior to their inclusion in the study.
- Outpatient (external) male or female over 18 years and under 50 years.
- 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).
- 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).
- 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.
Key exclusion criteria (14 listed)
- Patient with other nasal disease including: nasal polyps or nasal trauma recent.
- 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.
- Non-controlled asthma or who were under systemic corticosteroid treatment.
- Patient with Chronic Obstructive Pulmonary Disease.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
Related trials for Perennial Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
RecruitingPhase 2
PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
Rhinitis Allergic
RecruitingObservational study
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca AstraZeneca study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perennial Rhinitis and Seasonal Rhinitis, run by AstraZeneca at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016; AzTrials last refreshed its copy on 7 Nov 2026.