Trial Outcomes & Findings for A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler (NCT NCT01371786)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Day 1 at 2 minutes post dose

Results posted on

2012-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Ciclesonide Nasal Aerosol 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	Mometasone 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
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence Ciclesonide Nasal Aerosol /Mometsasone Aqueous n=7 Participants 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	Sequence Mometasone Aqueous / Ciclesonide Nasal Aerosol n=7 Participants 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 canistermometasone Aqueous (AQ) nasal spray : A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	36.1 years STANDARD_DEVIATION 13.62 • n=5 Participants	34.6 years STANDARD_DEVIATION 11.96 • n=7 Participants	35.4 years STANDARD_DEVIATION 12.34 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 at 2 minutes post dose

Population: Scintigraphic Population

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.

Outcome measures

Outcome measures
Measure	Ciclesonide Nasal Aerosol n=14 Participants A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister	Mometasone n=13 Participants A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose	99.48 percentage of radiolabeled Standard Deviation 0.98	86.28 percentage of radiolabeled Standard Deviation 11.99

SECONDARY outcome

Timeframe: Day 1 at 2 minutes post-dose

Population: Scintigraphic Population

The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, 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.

Outcome measures

Outcome measures
Measure	Ciclesonide Nasal Aerosol n=14 Participants A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister	Mometasone n=13 Participants A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose	0.03 percentage of radiolabeled Standard Deviation 0.11	1.58 percentage of radiolabeled Standard Deviation 1.94

SECONDARY outcome

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

Population: Scinitgraphic Population

The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.

Outcome measures

Outcome measures
Measure	Ciclesonide Nasal Aerosol n=14 Participants A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister	Mometasone n=13 Participants A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose	89.61 percentage of of radiolabled Standard Deviation 11.80	69.15 percentage of of radiolabled Standard Deviation 18.08

SECONDARY outcome

Timeframe: Day 1 at 2 minutes post-dose

Population: Scintigraphic Population

The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, 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.

Outcome measures

Outcome measures
Measure	Ciclesonide Nasal Aerosol n=14 Participants A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister	Mometasone n=13 Participants A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose	0.49 percentage of radiolabeled Standard Deviation 0.98	12.15 percentage of radiolabeled Standard Deviation 12.83

SECONDARY outcome

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

Population: Scinitigraphic Population

The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.

Outcome measures

Outcome measures
Measure	Ciclesonide Nasal Aerosol n=14 Participants A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister	Mometasone n=13 Participants A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose	0.98 percentage of radiolabeled Standard Deviation 1.71	13.15 percentage of radiolabeled Standard Deviation 12.63

Adverse Events

Ciclesonide Nasal Aerosol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Mometasone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ciclesonide Nasal Aerosol n=14 participants at risk A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister	Mometasone n=14 participants at risk A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/14 • 7 weeks	7.1% 1/14 • Number of events 1 • 7 weeks
Nervous system disorders Headache	14.3% 2/14 • Number of events 2 • 7 weeks	14.3% 2/14 • Number of events 2 • 7 weeks
Reproductive system and breast disorders Dysmenorrhoea	7.1% 1/14 • Number of events 1 • 7 weeks	0.00% 0/14 • 7 weeks

Additional Information

Respiratory Medical Director

Sunovion

Phone: 1-866-503-6351

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER