Trial Outcomes & Findings for Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis (NCT NCT00988247)

Last Updated: 2021-12-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

529 participants

Primary outcome timeframe

Baseline (Days -6 to 0), Day 1 to Week 30

Results posted on

2021-12-03

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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 beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	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.
Overall Study STARTED	418	111
Overall Study Safety Population	415	111
Overall Study Intent to Treat Population	414	110
Overall Study COMPLETED	335	85
Overall Study NOT COMPLETED	83	26

Reasons for withdrawal

Reasons for withdrawal
Measure	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 beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.	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.
Overall Study Adverse Event	17	3
Overall Study Withdrawal by Subject	44	13
Overall Study Pregnancy	1	2
Overall Study Lost to Follow-up	11	2
Overall Study Protocol Violation	4	5
Overall Study Sponsor requested withdrawal	3	1
Overall Study Other	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BDP HFA 320 µg/Day n=414 Participants 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.	Placebo n=110 Participants 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 n=524 Participants Total of all reporting groups
Age, Continuous	37.4 years STANDARD_DEVIATION 13.6 • n=93 Participants	35.7 years STANDARD_DEVIATION 12.9 • n=4 Participants	37.1 years STANDARD_DEVIATION 13.4 • n=27 Participants
Sex: Female, Male Female	286 Participants n=93 Participants	66 Participants n=4 Participants	352 Participants n=27 Participants
Sex: Female, Male Male	128 Participants n=93 Participants	44 Participants n=4 Participants	172 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=93 Participants	12 Participants n=4 Participants	57 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	369 Participants n=93 Participants	98 Participants n=4 Participants	467 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	7 participants n=93 Participants	2 participants n=4 Participants	9 participants n=27 Participants
Race/Ethnicity, Customized Asian	13 participants n=93 Participants	1 participants n=4 Participants	14 participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 participants n=93 Participants	0 participants n=4 Participants	3 participants n=27 Participants
Race/Ethnicity, Customized Black or African American	63 participants n=93 Participants	14 participants n=4 Participants	77 participants n=27 Participants
Race/Ethnicity, Customized White	341 participants n=93 Participants	97 participants n=4 Participants	438 participants n=27 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Body mass index	28.8 kg/m^2 STANDARD_DEVIATION 6.7 • n=93 Participants	28.4 kg/m^2 STANDARD_DEVIATION 6.7 • n=4 Participants	28.7 kg/m^2 STANDARD_DEVIATION 6.7 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Days -6 to 0), Day 1 to Week 30

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=414 Participants 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.	Placebo n=110 Participants 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.
Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks	-3.4 units on a scale Standard Error 0.11	-2.4 units on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: Baseline (Days -6 to 0), Day 1 to Week 30

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=414 Participants 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.	Placebo n=110 Participants 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.
Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks	-2.9 units on a scale Standard Error 0.11	-2.0 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline (Days -6 to 0), Day 1 to Week 52

Population: Intent to treat population.

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=414 Participants 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.	Placebo n=110 Participants 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.
Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks	-3.7 units on a scale Standard Error 0.12	-2.6 units on a scale Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline (Days -6 to 0), Day 1 to Week 52

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=414 Participants 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.	Placebo n=110 Participants 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.
Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks	-3.1 units on a scale Standard Error 0.11	-2.0 units on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: Day 0 (Baseline) and Week 30

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=202 Participants 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.	Placebo n=50 Participants 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.
Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline	-2.2 units on a scale Standard Error 0.09	-1.9 units on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Day 0 (Baseline) and Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=109 Participants 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.	Placebo n=23 Participants 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.
Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline	-2.0 units on a scale Standard Error 0.14	-1.5 units on a scale Standard Error 0.30

Adverse Events

BDP HFA 320 µg/Day

Serious events: 8 serious events

Other events: 216 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BDP HFA 320 µg/Day n=415 participants at risk 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.	Placebo n=111 participants at risk 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.
Renal and urinary disorders Nephrolithiasis	0.24% 1/415	0.00% 0/111
Investigations Intraocular pressure increased	0.24% 1/415	0.00% 0/111
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.48% 2/415	0.00% 0/111
Injury, poisoning and procedural complications Bladder injury	0.24% 1/415	0.00% 0/111
Reproductive system and breast disorders Menorrhagia	0.24% 1/415	0.00% 0/111
Reproductive system and breast disorders Pelvic adhesions	0.24% 1/415	0.00% 0/111
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.24% 1/415	0.00% 0/111
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.24% 1/415	0.00% 0/111
Injury, poisoning and procedural complications Fall	0.24% 1/415	0.00% 0/111
Injury, poisoning and procedural complications Humerus fracture	0.24% 1/415	0.00% 0/111
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.24% 1/415	0.00% 0/111
Reproductive system and breast disorders Ovarian cyst	0.00% 0/415	0.90% 1/111
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/415	0.90% 1/111
Infections and infestations Viral infection	0.00% 0/415	0.90% 1/111

Other adverse events

Other adverse events
Measure	BDP HFA 320 µg/Day n=415 participants at risk 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.	Placebo n=111 participants at risk 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.
Infections and infestations Nasopharyngitis	16.1% 67/415	12.6% 14/111
Infections and infestations Sinusitis	8.2% 34/415	7.2% 8/111
Infections and infestations Upper respiratory tract infection	10.4% 43/415	6.3% 7/111
Nervous system disorders Headache	6.7% 28/415	5.4% 6/111
Respiratory, thoracic and mediastinal disorders Epistaxis	10.6% 44/415	1.8% 2/111

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