A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

Perennial Allergic Rhinitis Clinical Trial

Official title:

A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067105
• Other study ID #: 060-635
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: June 8, 2012
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: June 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.

Description:

This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Subject has successfully completed all visits of Study 060-633.

• Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.

• Subject is male or female 12 years and older.

• Subject 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, clinical laboratory tests, and medical history.

• Subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at Visit 1). 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:

1. 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.

2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.

3. Abstinence.

Exclusion Criteria:

• Female subject who is pregnant or lactating.

• History of physical findings of nasal pathology, including nasal polyps.

• Subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• ciclesonide HFA 160 µg
ciclesonide HFA 160 µg once daily

Locations

Country	Name	City	State
United States	ISIS Clinical Research	Austin	Texas
United States	Sirius Clinical Research	Austin	Texas
United States	GR	Bethesda	Maryland
United States	Valley Clinical Research	Bethlehem	Pennsylvania
United States	TTS Research	Boerne	Texas
United States	Clinical Research Group of Montana	Bozeman	Montana
United States	National Allergy, Asthma, and Urticaria Centers	Charleston	South Carolina
United States	Asthma and Allergy Associates, PC	Colorado Springs	Colorado
United States	Storms Clinical Research Institute	Colorado Springs	Colorado
United States	Pharmaceutical Research and Consulting	Dallas	Texas
United States	Colorado Allergy and Asthma Centers	Denver	Colorado
United States	Allergy and Ashtma Research Group	Eugene	Oregon
United States	North Texas Institute for Clinical Trials	Fort Worth	Texas
United States	Allergy and Asthma Center of NC	High Point	North Carolina
United States	Allergy and Asthma Associates	Houston	Texas
United States	Allergy and Asthma Specialists Group	Huntington Beach	California
United States	Clinical Research Center of Indiana	Indianapolis	Indiana
United States	Kerrville Research Associates	Kerrville	Texas
United States	Baker Allergy, Asthma, and Dermatology Research Center	Lake Oswego	Oregon
United States	DataQuest Medical Research	Lawrenceville	Georgia
United States	Allergy and Asthma Consultants	Lilburn	Georgia
United States	California Allergy and Asthma Medical Group	Los Angeles	California
United States	Southern California Research	Mission Viejo	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Northeast Medical Research Associates, Inc.	North Dartmouth	Massachusetts
United States	CHOC PSF, AMC, Division of Allergy Asthma and Immunology	Orange	California
United States	California Allergy and Asthma Medical Group	Palmdale	California
United States	Western Sky Medical Research	Paso	Texas
United States	Allergy Associates Research Center	Portland	Oregon
United States	Asthma, Nasal Disease, and Allergy Research Center of New England	Providence	Rhode Island
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Biogenics Research Institute	San Antonio	Texas
United States	Southwest Allergy and Asthma Center	San Antonio	Texas
United States	Sylvana Research	San Antonio	Texas
United States	Allergy Associates Medical Group	San Diego	California
United States	ASTHMA Inc.	Seattle	Washington
United States	The Clinical Research Center	St. Louis	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Bensch Research Associates	Stockton	California
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Asthma and Allergy Research	Upland	Pennsylvania
United States	Atlanta Allergy and Asthma Clinic	Woodstock	Georgia
United States	Respiratory Medicine Research Institute of Michigan	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Experiencing Adverse Events (AEs)		Weeks 1-26	Yes
Primary	Percentage of Subjects Experiencing Serious Adverse Events (SAEs)		Weeks 1-26	Yes
Primary	Percentage of Subjects Who Discontinue Due to AEs.		Weeks 1-26	Yes
Secondary	Percentage of Subjects Experiencing Local Nasal AEs	Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.	Weeks 1-26	Yes
Secondary	Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Baseline and Weeks 1-26	No
Secondary	Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Baseline and Weeks 1-26	No
Secondary	Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Baseline and Months 1, 2, 3, 4, 5, and 6	No
Secondary	Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Baseline and Months 1, 2, 3, 4, 5, 6	No
Secondary	Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances	Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.	Weeks 0-12	No
Secondary	Number of Devices With Actuation Consistency	Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration	Weeks 0-6 and 6-12	No
Secondary	Percentage of Devices With Actuation Consistency	Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration	Weeks 0-6 and 6-12	No
Secondary	Number of Devices With Major Discrepancies	A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration	Weeks 0-6 and 6-12	No
Secondary	Percentage of Devices With Major Discrepancies	A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration	Weeks 0-6 and 6-12	No
Secondary	Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey	Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.	Weeks 6 and 12	No