Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies (NCT NCT00883168)

Results Overview

change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1791 participants

Primary outcome timeframe

day 1 to day 14

Results posted on

2013-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	MP29-02 azelastine HCl 548mcg / fluticasone propionate 200mcg	Azelastine Hcl azelastine HCl nasal spray	Fluticasone Propionate fluticasone propionate nasal spray	Placebo placebo nasal spray
Overall Study STARTED	448	445	450	448
Overall Study COMPLETED	434	430	431	433
Overall Study NOT COMPLETED	14	15	19	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MP29-02 n=448 Participants azelastine HCl 548mcg / fluticasone propionate 200mcg	Azelastine Hcl n=445 Participants azelastine HCl nasal spray	Fluticasone Propionate n=450 Participants fluticasone propionate nasal spray	Placebo n=448 Participants placebo nasal spray	Total n=1791 Participants Total of all reporting groups
Age, Categorical <=18 years	57 Participants n=5 Participants	38 Participants n=7 Participants	56 Participants n=5 Participants	46 Participants n=4 Participants	197 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	382 Participants n=5 Participants	390 Participants n=7 Participants	390 Participants n=5 Participants	387 Participants n=4 Participants	1549 Participants n=21 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	17 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants	45 Participants n=21 Participants
Age Continuous	35.6 years STANDARD_DEVIATION 14.5 • n=5 Participants	36.4 years STANDARD_DEVIATION 14.8 • n=7 Participants	34.2 years STANDARD_DEVIATION 14.5 • n=5 Participants	34.7 years STANDARD_DEVIATION 14.1 • n=4 Participants	35.2 years STANDARD_DEVIATION 14.5 • n=21 Participants
Sex: Female, Male Female	277 Participants n=5 Participants	271 Participants n=7 Participants	280 Participants n=5 Participants	269 Participants n=4 Participants	1097 Participants n=21 Participants
Sex: Female, Male Male	171 Participants n=5 Participants	174 Participants n=7 Participants	170 Participants n=5 Participants	179 Participants n=4 Participants	694 Participants n=21 Participants
Region of Enrollment United States	448 participants n=5 Participants	445 participants n=7 Participants	450 participants n=5 Participants	448 participants n=4 Participants	1791 participants n=21 Participants

PRIMARY outcome

Timeframe: day 1 to day 14

Population: Intent to Treat (ITT) population includes all subjects who had at least one post baseline dose efficacy evaluation

change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.

Outcome measures

Outcome measures
Measure	MP29-02 n=448 Participants azelastine HCl 548mcg / fluticasone propionate 200mcg	Azelastine Hcl n=445 Participants azelastine HCl nasal spray	Fluticasone Propionate n=450 Participants fluticasone propionate nasal spray	Placebo n=448 Participants placebo nasal spray
Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)	-5.5 units on a scale Standard Deviation 5.2	-4.8 units on a scale Standard Deviation 4.8	-4.9 units on a scale Standard Deviation 4.7	-3.4 units on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: day 1 to day 14

Population: Intent to Treat (ITT) population includes all subjects who received at least one post baseline efficacy evaluation

change from baseline in 12-hour instantaneous total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improved condition.

Outcome measures

Outcome measures
Measure	MP29-02 n=448 Participants azelastine HCl 548mcg / fluticasone propionate 200mcg	Azelastine Hcl n=443 Participants azelastine HCl nasal spray	Fluticasone Propionate n=450 Participants fluticasone propionate nasal spray	Placebo n=448 Participants placebo nasal spray
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)	-5.0 units on a scale Standard Deviation 5.3	-4.3 units on a scale Standard Deviation 4.9	-4.7 units on a scale Standard Deviation 4.9	-3.1 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: day 1 to day 14

Population: Intent to treat (ITT)population includes all subjects(18 years or older) who had at least one post baseline efficacy evaluation

adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.

Outcome measures

Outcome measures
Measure	MP29-02 n=381 Participants azelastine HCl 548mcg / fluticasone propionate 200mcg	Azelastine Hcl n=394 Participants azelastine HCl nasal spray	Fluticasone Propionate n=384 Participants fluticasone propionate nasal spray	Placebo n=393 Participants placebo nasal spray
Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	-1.6 units on a scale Standard Deviation 1.3	-1.4 units on a scale Standard Deviation 1.3	-1.6 units on a scale Standard Deviation 1.2	-1.0 units on a scale Standard Deviation 1.2

Adverse Events

MP29-02

Serious events: 1 serious events

Other events: 57 other events

Deaths: 0 deaths

Azelastine Hcl

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Fluticasone Propionate

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MP29-02 n=448 participants at risk azelastine HCl 548mcg / fluticasone propionate 200mcg	Azelastine Hcl n=449 participants at risk azelastine HCl nasal spray	Fluticasone Propionate n=450 participants at risk fluticasone propionate nasal spray	Placebo n=451 participants at risk placebo nasal spray
Injury, poisoning and procedural complications lacerated right hand	0.22% 1/448 • Number of events 1	0.00% 0/449	0.00% 0/450	0.00% 0/451
Infections and infestations pyogenic arthritis right elbow	0.00% 0/448	0.00% 0/449	0.00% 0/450	0.22% 1/451 • Number of events 1

Other adverse events

Other adverse events
Measure	MP29-02 n=448 participants at risk azelastine HCl 548mcg / fluticasone propionate 200mcg	Azelastine Hcl n=449 participants at risk azelastine HCl nasal spray	Fluticasone Propionate n=450 participants at risk fluticasone propionate nasal spray	Placebo n=451 participants at risk placebo nasal spray
Gastrointestinal disorders dysgusia	4.7% 21/448 • Number of events 21	5.1% 23/449 • Number of events 23	0.22% 1/450 • Number of events 1	0.00% 0/451
Nervous system disorders headache	2.2% 10/448 • Number of events 10	3.1% 14/449 • Number of events 14	1.8% 8/450 • Number of events 8	0.89% 4/451 • Number of events 4
Respiratory, thoracic and mediastinal disorders epistaxis	2.2% 10/448 • Number of events 10	1.3% 6/449 • Number of events 6	1.3% 6/450 • Number of events 6	1.8% 8/451 • Number of events 8
General disorders oropharyngial pain	1.1% 5/448 • Number of events 5	0.45% 2/449 • Number of events 2	1.3% 6/450 • Number of events 6	0.44% 2/451 • Number of events 2
Nervous system disorders somnolence	1.1% 5/448 • Number of events 5	0.45% 2/449 • Number of events 2	0.00% 0/450	0.22% 1/451 • Number of events 1
Infections and infestations nasopharyngitis	0.67% 3/448 • Number of events 3	0.00% 0/449	0.67% 3/450 • Number of events 3	1.1% 5/451 • Number of events 5
Respiratory, thoracic and mediastinal disorders mucosal erosion	0.45% 2/448 • Number of events 2	0.00% 0/449	1.1% 5/450 • Number of events 5	0.22% 1/451 • Number of events 1
Nervous system disorders sinus headache	0.22% 1/448 • Number of events 1	0.00% 0/449	0.67% 3/450 • Number of events 3	1.1% 5/451 • Number of events 5

Additional Information

David Ginsberg,D.O.

Meda Pharmaceuticals, Inc.

Phone: 732 564-2364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators participating in multicenter studies must agree not to present data gathered individually or by a subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and Meda Pharmaceuticals. Meda Pharmaceuticals requests that it receive copies of any intended communication reasonably in advance (at least 15 working days for an abstract or oral presentation and 45 working days for a manuscript)
Publication restrictions are in place

Restriction type: OTHER