Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)

NCT00458835 | Completed Phase 4 Results

• 1 other identifier: BY9010/M1-422
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Comparison of Systemic Exposure Measured by AUC, ng*hr/L, (Area Under the Serum Concentration) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.

  The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ \[ciclesonide\] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. It was anticipated that only a limited number of des-ciclesonide concentrations would exceed the lower limit of quantification (LLOQ) of 10 pg/mL for ciclesonide aqueous nasal spray. AUC for the aqueous nasal spray could not be determined due to the fact that there were too few analysis samples that produced values above the LLOQ.

  5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.

Secondary Outcomes (1)

• Comparison of Systemic Exposure Measured by Cmax, pg/mL, (Highest Concentration of Drug in the Blood) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.

  5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.

Study Arms (3)

Ciclesonide 300 mcg intranasally via aqueous nasal spray

ACTIVE COMPARATOR

Drug: Ciclesonide

Ciclesonide 300 mcg intranasally via HFA nasal aerosol

ACTIVE COMPARATOR

Drug: Ciclesonide

Ciclesonide 320 mcg orally inhaled via HFA MDI

ACTIVE COMPARATOR

Drug: Ciclesonide

Interventions

Ciclesonide DRUG

Ciclesonide 300 mcg intranasally via HFA nasal aerosol; Ciclesonide 300 mcg intranasally via aqueous nasal spray; Ciclesonide 320 mcg orally inhaled via HFA MDI

Eligibility Criteria

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

You may qualify if:

• Written informed consent and HIPAA
• Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a body weight \>50 kg
• General good health
• Ability to use oral inhaler

You may not qualify if:

• Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
• Participation in any investigational drug trial within the 30 days before Screening Visit and thereafter
• History or current clinically relevant allergies or idiosyncrasy to drugs or food
• History of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations
• Any contraindication to nasally administered corticosteroids
• History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)\] within the 30 days before Screening Visit, or development of a respiratory infection during the Screening Period
• History or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years
• Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding Screening Visit

Sponsors & Collaborators

• Covis Pharma S.à.r.l.: lead

Study Sites (1)

ALTANA Pharma

Austin, Texas, United States

Location

Related Publications (1)

• Nave R, Herzog R, Laurent A, Wingertzahn MA. Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers. Clin Ther. 2009 Dec;31(12):2988-99. doi: 10.1016/j.clinthera.2009.12.002.

  PMID: 20110036 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trials Interest
• Organization: Covis Pharma

CTInterest@covispharma.com

1-877-374 -4177

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: April 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 9, 2023
• Results First Posted: March 2, 2022

Record last verified: 2023-02

Locations

US (1)