Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00988247
• Collaborator: (none)
• Enrollment: 529
• Locations: 34
• Arms: 2
• Actual Duration (Months): 15.9
• Patients Per Site: 15.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a "dry" nasal aerosol which may be preferred by some patients.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Perennial	Drug: Beclomethasone dipropionate; Drug: Placebo Nasal Aerosol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 529 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Long-term Efficacy and Safety of BDP HFA Nasal Aerosol (320 mcg, Once Daily) in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)
• Actual Study Start Date: Oct 31, 2009
• Actual Primary Completion Date: Feb 28, 2011
• Actual Study Completion Date: Feb 28, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BDP HFA 320 µg/day During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.	Drug: Beclomethasone dipropionate; Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 30-weeks (or 52-weeks, depending upon investigator site).; Other Names: QNASL(TM)
Placebo Comparator: Placebo During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.	Drug: Placebo Nasal Aerosol; Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks [Baseline (Days -6 to 0), Day 1 to Week 30]

   Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.

Secondary Outcome Measures

1. Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks [Baseline (Days -6 to 0), Day 1 to Week 30]

   Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.

2. Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks [Baseline (Days -6 to 0), Day 1 to Week 52]

   Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.

3. Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks [Baseline (Days -6 to 0), Day 1 to Week 52]

   Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.

4. Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [Day 0 (Baseline) and Week 30]

   The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. Week 30 scores were compared to baseline scores. A negative change score indicates improvement.

5. Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [Day 0 (Baseline) and Week 52]

   The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. Week 52 scores were compared to baseline scores. A negative change score indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects, 12 years of age or older as of the Screening Visit (SV)

• 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 subject at increased risk during the study

• A history of PAR to a relevant perennial allergen for a minimum of two years immediately preceding the study Screening Visit (SV). The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past, and in the investigator's judgment is expected to require treatment throughout the entire study

• A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the diluent control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (SV) is acceptable

• Other criteria apply

Exclusion Criteria:

• History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, including nasal piercing, or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to Screening Visit [SV])

• Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study

• History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis, or influenza within the 14 days preceding the Screening Visit (SV) or development of a respiratory infection during the Run-In Period

• Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists and any controller drugs (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable.

• Other criteria apply

Randomization Criteria

• Subject continues to be in general good health, meeting the selection criteria

• Subject has a minimum subject-reported reflective TNSS of an average of 5 (out of a possible 12) on the last 7 days during the Run-In Period

• The subject-reported scores for rhinorrhea or nasal congestion must be an average of 2 or greater during the last 7 days of the Run-In Period

• Each subject must have adequately completed the electronic AR Assessment Diary (failure is defined as missing the diary entry on more than 2 calendar days during the last 7 days of the Run-In Period)

• Other criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Clinical Sudy Site	Oxford	Alabama	United States	36203
2	Teva Clinical Study Site	Encinitas	California	United States	92024
3	Teva Clinical Study Site	Huntington Beach	California	United States	92647
4	Teva Clinical Study Site	San Diego	California	United States	92120
5	Teva Clinical Study Site	Stockton	California	United States	95207
6	Teva Clinical Study Site	Colorado Springs	Colorado	United States	80907
7	Teva Clinical Study Site	Atlanta	Georgia	United States	30342
8	Teva Clinical Study Site	Stockbridge	Georgia	United States	30281
9	Teva Clinical Study Site	Normal	Illinois	United States	61761
10	Teva Clinical Study Site	Lenexa	Kansas	United States	66215
11	Teva Clinical Study Site	Overland Park	Kansas	United States	66210
12	Teva Clinical Study Site	Metairie	Louisiana	United States	70006
13	Teva Clinical Study Site	Wheaton	Maryland	United States	20902
14	Teva Clinical Study Site	Ypsilanti	Michigan	United States	48197
15	Teva Clinical Study Site	Minneapolis	Minnesota	United States	55402
16	Teva Clinical Study Site	Plymouth	Minnesota	United States	55441
17	Teva Clinical Study Site	Bozeman	Montana	United States	59718
18	Teva Clinical Study Site	North Syracuse	New York	United States	13212
19	Teva Clinical Study Site	Rochester	New York	United States	14618
20	Teva Clinical Study Site	Rockville Center	New York	United States	11570
21	Teva Clinical Study Site	High Point	North Carolina	United States	27262
22	Teva Clinical Study Site	Cincinnati	Ohio	United States	45231
23	Teva Clinical Study Site	Sylvania	Ohio	United States	43560
24	Teva Clinical Study Site	Eugene	Oregon	United States	97401
25	Teva Clinical Study Site	Bethlehem	Pennsylvania	United States	18020
26	Teva Clinical Study Site	Collegeville	Pennsylvania	United States	19426
27	Teva Clinical Study Site	Dallas	Texas	United States	75231
28	Teva Clinical Study Site	El Paso	Texas	United States	79903
29	Teva Clinical Study Site	Houston	Texas	United States	77054
30	Teva Clinical Study Site	Kerrville	Texas	United States	78028
31	Teva Clinical Study Site	San Antonio	Texas	United States	78229
32	Teva Clinical Study Site	Vancouver	Washington	United States	98664
33	Teva Clinical Study Site	Greenfield	Wisconsin	United States	53228
34	Teva Clinical Study Site	West Allis	Wisconsin	United States	53227

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Study Director, Teva Branded

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT00988247
• Other Study ID Numbers: BDP-AR-303
• First Posted: Oct 2, 2009
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.: Rhinitis, Allergic, Perennial; BDP-HFA; Hay fever; Allergic rhinitis
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Beclomethasone

Study Results

Participant Flow

Recruitment Details	A total of 857 patients were screened and 775 patients were enrolled in the study and participated in the Run-in Period. Of the 775 enrolled patients, 529 were randomized to study treatment.
Pre-assignment Detail	During the 7 to 21 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their daily seasonal rhinitis symptoms to determine eligibility for randomization.

Arm/Group Title	BDP HFA 320 µg/Day	Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Period Title: Overall Study
STARTED	418	111
Safety Population	415	111
Intent to Treat Population	414	110
COMPLETED	335	85
NOT COMPLETED	83	26

Baseline Characteristics

Arm/Group Title	BDP HFA 320 µg/Day	Placebo	Total
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.	Total of all reporting groups
Overall Participants	414	110	524
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.4 (13.6)	35.7 (12.9)	37.1 (13.4)
Sex: Female, Male (Count of Participants)
Female	286 69.1%	66 60%	352 67.2%
Male	128 30.9%	44 40%	172 32.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	45 10.9%	12 10.9%	57 10.9%
Not Hispanic or Latino	369 89.1%	98 89.1%	467 89.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	7 1.7%	2 1.8%	9 1.7%
Asian	13 3.1%	1 0.9%	14 2.7%
Native Hawaiian or Other Pacific Islander	3 0.7%	0 0%	3 0.6%
Black or African American	63 15.2%	14 12.7%	77 14.7%
White	341 82.4%	97 88.2%	438 83.6%
Unknown or Not Reported	1 0.2%	0 0%	1 0.2%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.8 (6.7)	28.4 (6.7)	28.7 (6.7)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks
Description	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.
Time Frame	Baseline (Days -6 to 0), Day 1 to Week 30

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	BDP HFA 320 µg/Day	Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Measure Participants	414	110
Least Squares Mean (Standard Error) [units on a scale]	-3.4 (0.11)	-2.4 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BDP HFA 320 µg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.
Method of Estimation	Estimation Parameter	LS mean treatment diff from placebo]
	Estimated Value	-0.97
	Confidence Interval	(2-Sided) 95%; -1.5 to -0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks
Description	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.
Time Frame	Baseline (Days -6 to 0), Day 1 to Week 30

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	BDP HFA 320 µg/Day	Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Measure Participants	414	110
Least Squares Mean (Standard Error) [units on a scale]	-2.9 (0.11)	-2.0 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BDP HFA 320 µg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.
Method of Estimation	Estimation Parameter	LS mean treatment diff from placebo]
	Estimated Value	-0.96
	Confidence Interval	(2-Sided) 95%; -1.4 to -0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks
Description	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.
Time Frame	Baseline (Days -6 to 0), Day 1 to Week 52

Outcome Measure Data

Analysis Population Description

Intent to treat population.

Arm/Group Title	BDP HFA 320 µg/Day	Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Measure Participants	414	110
Least Squares Mean (Standard Error) [units on a scale]	-3.7 (0.12)	-2.6 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BDP HFA 320 µg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.
Method of Estimation	Estimation Parameter	LS mean treatment diff from placebo]
	Estimated Value	-1.09
	Confidence Interval	(2-Sided) 95%; -1.6 to -0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks
Description	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.
Time Frame	Baseline (Days -6 to 0), Day 1 to Week 52

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	BDP HFA 320 µg/Day	Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Measure Participants	414	110
Least Squares Mean (Standard Error) [units on a scale]	-3.1 (0.11)	-2.0 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BDP HFA 320 µg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.
Method of Estimation	Estimation Parameter	LS mean treatment diff from placebo]
	Estimated Value	-1.10
	Confidence Interval	(2-Sided) 95%; -1.6 to -0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
Description	The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. Week 30 scores were compared to baseline scores. A negative change score indicates improvement.
Time Frame	Day 0 (Baseline) and Week 30

Outcome Measure Data

Analysis Population Description

The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.

Arm/Group Title	BDP HFA 320 µg/Day	Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Measure Participants	202	50
Least Squares Mean (Standard Error) [units on a scale]	-2.2 (0.09)	-1.9 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BDP HFA 320 µg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.143
	Comments
	Method	ANCOVA
	Comments	ANCOVA with treatment, baseline and pooled center in the model.
Method of Estimation	Estimation Parameter	treatment difference
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 95%; -0.7 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
Description	The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. Week 52 scores were compared to baseline scores. A negative change score indicates improvement.
Time Frame	Day 0 (Baseline) and Week 52

Outcome Measure Data

Analysis Population Description

The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.

Arm/Group Title	BDP HFA 320 µg/Day	Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Measure Participants	109	23
Least Squares Mean (Standard Error) [units on a scale]	-2.0 (0.14)	-1.5 (0.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BDP HFA 320 µg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.130
	Comments
	Method	ANCOVA
	Comments	ANCOVA with treatment, baseline and pooled center in the model.
Method of Estimation	Estimation Parameter	treatment difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -1.1 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	BDP HFA 320 µg/Day		Placebo
Arm/Group Description	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.		During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
All Cause Mortality
	BDP HFA 320 µg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BDP HFA 320 µg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/415 (1.9%)		3/111 (2.7%)
Infections and infestations
Viral infection	0/415 (0%)		1/111 (0.9%)
Injury, poisoning and procedural complications
Bladder injury	1/415 (0.2%)		0/111 (0%)
Fall	1/415 (0.2%)		0/111 (0%)
Humerus fracture	1/415 (0.2%)		0/111 (0%)
Investigations
Intraocular pressure increased	1/415 (0.2%)		0/111 (0%)
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome	1/415 (0.2%)		0/111 (0%)
Arthralgia	0/415 (0%)		1/111 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	2/415 (0.5%)		0/111 (0%)
Squamous cell carcinoma	1/415 (0.2%)		0/111 (0%)
Renal and urinary disorders
Nephrolithiasis	1/415 (0.2%)		0/111 (0%)
Reproductive system and breast disorders
Menorrhagia	1/415 (0.2%)		0/111 (0%)
Pelvic adhesions	1/415 (0.2%)		0/111 (0%)
Ovarian cyst	0/415 (0%)		1/111 (0.9%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/415 (0.2%)		0/111 (0%)
Other (Not Including Serious) Adverse Events
	BDP HFA 320 µg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	216/415 (52%)		37/111 (33.3%)
Infections and infestations
Nasopharyngitis	67/415 (16.1%)		14/111 (12.6%)
Sinusitis	34/415 (8.2%)		8/111 (7.2%)
Upper respiratory tract infection	43/415 (10.4%)		7/111 (6.3%)
Nervous system disorders
Headache	28/415 (6.7%)		6/111 (5.4%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	44/415 (10.6%)		2/111 (1.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.