Trial Outcomes & Findings for Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR) (NCT NCT01024608)

Last Updated: 2021-12-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

340 participants

Primary outcome timeframe

Baseline (Days -3 to 0), and Days 1-15

Results posted on

2021-12-03

Participant Flow

A total of 484 patients were screened and 463 patients were enrolled in the study and participated in the Run-in Period. Of the 463 enrolled patients, 340 were randomized to study treatment.

During the 7 to 10 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their seasonal rhinitis symptoms twice daily to determine eligibility for randomization.

Participant milestones

Participant milestones
Measure	BDP HFA 320 µg/Day During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Overall Study STARTED	169	171
Overall Study Intent to Treat Population	167	171
Overall Study Safety Population	167	171
Overall Study COMPLETED	165	167
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	BDP HFA 320 µg/Day During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Protocol Violation	0	3
Overall Study Never received study treatment	2	0

Baseline Characteristics

Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BDP HFA 320 µg/Day n=167 Participants During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo n=171 Participants During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.	Total n=338 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 13.4 • n=5 Participants	38.0 years STANDARD_DEVIATION 13.3 • n=7 Participants	38.6 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	97 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	74 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	52 Participants n=5 Participants	49 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=5 Participants	122 Participants n=7 Participants	237 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	23 participants n=5 Participants	26 participants n=7 Participants	49 participants n=5 Participants
Race/Ethnicity, Customized White	142 participants n=5 Participants	142 participants n=7 Participants	284 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Days -3 to 0), and Days 1-15

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=167 Participants During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo n=171 Participants During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period	-2.0 units on a scale Standard Error 0.16	-1.0 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline (Days -3 to 0), and Days 1-15

Population: Intent to treat population

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

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=167 Participants During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo n=171 Participants During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period	-1.7 units on a scale Standard Error 0.15	-0.8 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Day 0 (Baseline), Day 15

Population: The RQLQ population, subset of ITT population, included only those participants over the age of 18 years (fluent in English) with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.

The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=129 Participants During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo n=121 Participants During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline	-1.2 units on a scale Standard Error 0.12	-0.8 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline (Days -3 to 0), and Days 1-15

Population: Intent to treat population

Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities). The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement.

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=167 Participants During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo n=171 Participants During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period	-1.3 units on a scale Standard Error 0.13	-0.7 units on a scale Standard Error 0.12

Adverse Events

BDP HFA 320 µg/Day

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BDP HFA 320 µg/Day n=167 participants at risk During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo n=171 participants at risk During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Vascular disorders Hypertensive crisis	0.60% 1/167	0.00% 0/171

Other adverse events

Other adverse events
Measure	BDP HFA 320 µg/Day n=167 participants at risk During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	Placebo n=171 participants at risk During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	6.6% 11/167	5.8% 10/171

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 215-591-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER