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)

NCT00659048 | Completed Phase 3

• 1 other identifier: BY9010/M1-408
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

Perennial Allergic Rhinitis; Ciclesonide; PAR

Outcome Measures

Primary Outcomes (1)

• 24 h plasma cortisol profiles and urinary cortisol

  53 days

Secondary Outcomes (3)

• 24-hour urinary cortisol will be monitored at the following times

  53 days

• Adverse events

  53 days

• vital signs

  53 days

Study Arms (2)

1

ACTIVE COMPARATOR

Ciclesonide 200µg

Drug: Ciclesonide

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ciclesonide DRUG

Ciclesonide 200µg versus Placebo

1

Placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Previous participation in an intranasal ciclesonide study.
• Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (S0).
• Exposure to corticosteroids for any indication, chronic or intermittent (e.g.: asthma, contact dermatitis), during the past 2 months, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
• Use of topical corticosteroids in concentrations in excess of the equivalent of 1% hydrocortisone for dermatological conditions during the past 1 month, or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study.
• Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables.
• Chronic or clinically relevant acute infections.
• Vegetarian diet or other unusual dietary habits that would preclude the subject's acceptance of standardized meals.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Altana/Nycomed

San Antonio, Texas, 78229, United States

Location

Related Links

• BY9010-M1-408-RDS-2005-12-05.pdf

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 16, 2008
• Study Start: December 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: December 1, 2005
• Last Updated: December 1, 2016

Record last verified: 2016-10

Locations

US (1)