To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatm… (NCT00658918) | Clinical Trial Compass
CompletedPhase 3
To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
United States120 participantsStarted 2004-09
Plain-language summary
The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure serum concentrations of ciclesonide and its active metabolite under steady state conditions at three time points corresponding to the presumed peak and trough exposure after six weeks of administration.
In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were summarized.
Who can participate
Age range2 Years – 5 Years
SexALL
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Inclusion criteria
✓. Male or female between the ages of 2 and 5 years, inclusive
✓. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial
✓. A demonstrated sensitivity to at least one allergen known to induce PAR through a standard prick skin test within one year of study start. A positive test is defined as a wheal diameter at least 3mm larger than the control wheal for th eprick test
✓. Parent or legal guardian is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
✓. A history of PAR for a minimum of 3 months preceding the study screening visit (B0). The PAR must have been of sufficient severity to require treatment (either continuous or intermittent) in the past and in the investigators judgment is expected to continue to require treatment for the study duration.
Exclusion criteria
✕. History of physical findings of nasal pathology, including nasal polyps (within the last 60 days) or other clinically significant respiratory tract malformations, recent nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days).
What they're measuring
1
Spontaneous and elicited adverse events (AEs)
Timeframe: 6 weeks
2
Vital signs
Timeframe: 6 weeks
3
Cortisol (24-hour urine. AM plasma)
Timeframe: 6 weeks
4
clinical laboratory parameters
Timeframe: 6 weeks
5
Physical examination including ENT exam
Timeframe: 6 weeks
6
Intraocular pressure (IOP) assessment
Timeframe: 6 weeks
7
serum concentrations of ciclesonide and its active metabolite will be measured following 6 weeks treatment at three time points corresponding to presumed peak and trough exposure
✕. Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) or at any time during the trial
✕. A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
✕. History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit, or development of a respiratory infection during the Screening Visit (B0)
✕. History of a positive test for HIV, hepatitis B or hepatitis C.
✕. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists and any controller drugs (e.g. theophylline, leukotrienes, etc.) intermittent use of b-agonists is acceptable
✕. Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the screening visit (B0) and during the entire screening period and treatment duration
✕. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0).