Phase 3
N=824
A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Perennial Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01067105 ↗Enrolled (actual)
824
Serious AEs
1.8%
Results posted
Jun 2012
Primary outcome: Primary: Percentage of Subjects Experiencing Adverse Events (AEs) — 51.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ciclesonide HFA 160 μg (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Experiencing Adverse Events (AEs) |
51.5 | — |
| PRIMARY Percentage of Subjects Experiencing Serious Adverse Events (SAEs) |
1.8 | — |
| PRIMARY Percentage of Subjects Who Discontinue Due to AEs. |
1.7 | — |
| SECONDARY Percentage of Subjects Experiencing Local Nasal AEs |
29.4 | — |
| SECONDARY Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. |
-0.50 | — |
| SECONDARY Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. |
-0.54 | — |
| SECONDARY Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. |
-0.18; -0.48; -0.64; -0.69; -0.64; -0.54 | — |
| SECONDARY Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. |
-0.26; -0.55; -0.66; -0.70; -0.67; -0.57 | — |
| SECONDARY Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances |
112.29; 112.23 | — |
| SECONDARY Number of Devices With Actuation Consistency |
556; 531 | — |
| SECONDARY Percentage of Devices With Actuation Consistency |
71.5; 72.5 | — |
| SECONDARY Number of Devices With Major Discrepancies |
144; 117 | — |
| SECONDARY Percentage of Devices With Major Discrepancies |
18.5; 16.0 | — |
| SECONDARY Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey |
794; 744 | — |
Summary
6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.
Eligibility Criteria
Inclusion Criteria
- Subject has successfully completed all visits of Study 060-633.
- Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Subject is male or female 12 years and older.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, clinical laboratory tests, and medical history.
- Subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at Visit 1). Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
- An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
- Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- Abstinence.
Exclusion Criteria
- Female subject who is pregnant or lactating.
- History of physical findings of nasal pathology, including nasal polyps.
- Subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.
Data sourced from ClinicalTrials.gov (NCT01067105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.