A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler

NCT01371786 | Completed Phase 1 Results

• 1 other identifier: 060-102
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14 patients with symptomatic allergic rhinitis, aged 18-65 years.

Conditions

Allergic Rhinitis (AR)

Keywords

Ciclesonide; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose

  The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.

  Day 1 at 2 minutes post dose

Secondary Outcomes (4)

• Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose

  Day 1 at 2 minutes post-dose

• Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose

  Average of 2, 4, 6, 8 and 10 minutes post dose

• Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose

  Day 1 at 2 minutes post-dose

• Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose

  Average of 2, 4, 6, 8, and 10 minutes post dose

Study Arms (2)

ciclesonide nasal aerosol

EXPERIMENTAL

A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle

Drug: ciclesonide nasal aerosol

mometasone

ACTIVE COMPARATOR

A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister

Drug: mometasone Aqueous (AQ) nasal spray

Interventions

ciclesonide nasal aerosol DRUG

A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister

ciclesonide nasal aerosol

mometasone Aqueous (AQ) nasal spray DRUG

A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle

mometasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has give written informed consent and agrees to adhere to concomitant medication withholding periods, prior to participation.
• Patient is aged 18-65 years, inclusive.
• Patient has a Body Mass Index (BMI) of 18-30 kg/m2, inclusive
• Patient must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).
• A history of perennial or seasonal allergic rhinitis confirmed on GP report, or clinical diagnosis of perennial or seasonal allergic rhinitis confirmed at screening.
• A demonstrated sensitivity at the Screening visit, or within the 90 days prior to screening, to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) or SAR (grass pollen, tree pollen and weed pollen) using a 3 mm response to a standard skin prick test. The patient's positive allergen test must be consistent with the medical history of PAR/SAR.
• Must be willing and able to communicate and participate in the whole study.
• Patients must refrain from taking medication for allergic rhinitis, from Screening until completion of second dosing period.
• Patients, if female, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
• An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
• Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
• True abstinence, when this is in line with the preferred and usual lifestyle of the patient (if the patient is usually not sexually active but becomes active, they with their partner, must use an acceptable method of birth control).

You may not qualify if:

• Female patient who is pregnant or lactating.
• Patient has radiation exposure from clinical trials, including that from the present study, excluding background radiation but including diagnostic X rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
• Patient has an abnormality on physical examination that, in the investigator's opinion, would affect nasal airway resistance, including: nasal jewelry or piercings; nasal pathology such as nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations.
• Patient has a history of cocaine or glue sniffing.
• Nasal surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to the Screening visit.
• Patient is a smoker (based on results of breath carbon monoxide testing at screening; ie, ≥10 ppm).
• Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta agonists is acceptable. Use of short acting beta agonists for exercise induced bronchospasm will be allowed.
• Patient has a history of any chronic respiratory disorder including active or quiescent pulmonary tuberculosis.
• Patient has a history of adverse reaction or allergy to ciclesonide, mometasone, other corticosteroids, or formulation excipients.
• Patient has a Screening forced expiratory volume (FEV1) \<80% of the predicted value for their age, sex, height and race.
• Patient has had an upper respiratory tract infection (excluding otitis media) within 14 days of first dosing period, or a lower respiratory tract infection within 3 months of the first study day.
• Previous participation in an intranasal ciclesonide HFA nasal aerosol study; participation in any investigational drug trial within the 60 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
• History of alcohol or drug abuse within 2 years preceding the Screening visit.
• Study participation by clinical investigator site employees and/or their relatives or by more than one patient from the same household.
• Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the patients availability to participate in the clinical trial:

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

Quotient Clinical

Ruddington Fields, Ruddington, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Both the formulations used in this study were radiolabeled and not the individual corticosteroid molecules. Therefore the distribution of the corticosteroid molecules over 10 minutes post-administration was not quantified.

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion

1-866-503-6351

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 10, 2012
• Results First Posted: September 6, 2012

Record last verified: 2012-09

Locations

GB (1)