Phase 3
Completed N=107
Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT01133626 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment — 0.90; 0.95; 0.31 ratio
Summary
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment |
0.90; 0.95; 0.31 | — |
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- Male or female subjects 12-45 years of age
- Documented history of perennial allergic rhinitis
- General good health
- Other criteria apply
Exclusion Criteria
- History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)
- Participation in any investigational drug study 30 days preceding Screening Visit 1
- History of respiratory infection/disorder with 14 days preceding Screening Visit 1
- Use of any prohibited concomitant medications
Data sourced from ClinicalTrials.gov (NCT01133626). 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. Informational only — not medical advice.