Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray Whe… (NCT00659048) | Clinical Trial Compass
CompletedPhase 3
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)
United States106 participantsStarted 2004-12
Plain-language summary
The primary objective of this study is to demonstrate that there are no clinically relevant additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and tolerability of the combined dosing regimen of orally inhaled HFA-BDP and ciclesonide nasal spray.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female, 18 - 60 years of age.
✓. 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 history of PAR for a minimum of one year immediately preceding the Screening Visit.
✓. A demonstrated sensitivity to at least one allergen known to induce PAR through a standard prick or intradermal test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the prick test, and 7 mm or greater than the control for the intradermal test. Documentation of a positive result within 12 months prior to the Screening Visit is acceptable.
✓. Females of child-bearing potential are currently taking and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Women of childbearing potential, or less than 1 year postmenopausal, will require a negative plasma pregnancy test at the Screening Visit as well as at last on-treatment visit.
✓. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and compliance with all study requirements (visits, record keeping, etc).
✓. Normal body weight as evidenced by a Body Mass Index (BMI) between ³ 18 and 31 kg/m², and a body weight \> 45 kg.
Exclusion criteria
✕. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period.
What they're measuring
1
24 h plasma cortisol profiles and urinary cortisol
✕. History or 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).
✕. Participation in any investigational drug trial within the 30 days preceding the Screening Visit (S0).
✕. A known hypersensitivity to any corticosteroid or any of the excipients in the formulations.
✕. History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food.
✕. History of alcohol or drug abuse within the preceding two years.
✕. History of a positive test for HIV, hepatitis B or hepatitis C.
✕. Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit (S0) and during entire study duration.