Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies (NCT NCT00660517)

Results Overview

change from baseline in the 12 hour reflective total nasal symptoms 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

607 participants

Primary outcome timeframe

day 1 to day14

Results posted on

2012-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day	Azelastine Hcl 548 Mcg azelastine Hcl nasal spray one spray per nostril two times a day	Fluticasone Propionate 200 Mcg fluticasone propionate nasal spray one spray per nostril two times a day	Placebo nasal spray
Overall Study STARTED	153	152	151	151
Overall Study COMPLETED	145	144	144	144
Overall Study NOT COMPLETED	8	8	7	7

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	Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg n=153 Participants azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day	Azelastine Hcl 548 Mcg n=152 Participants azelastine Hcl nasal spray one spray per nostril two times a day	Fluticasone Propionate 200 Mcg n=151 Participants fluticasone propionate nasal spray one spray per nostril two times a day	Placebo n=151 Participants nasal spray	Total n=607 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	43 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	136 Participants n=5 Participants	132 Participants n=7 Participants	137 Participants n=5 Participants	131 Participants n=4 Participants	536 Participants n=21 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	28 Participants n=21 Participants
Age Continuous	39.5 years STANDARD_DEVIATION 14.2 • n=5 Participants	39.5 years STANDARD_DEVIATION 14.1 • n=7 Participants	38.1 years STANDARD_DEVIATION 14.2 • n=5 Participants	39.9 years STANDARD_DEVIATION 14.7 • n=4 Participants	39.2 years STANDARD_DEVIATION 14.3 • n=21 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	97 Participants n=7 Participants	100 Participants n=5 Participants	102 Participants n=4 Participants	396 Participants n=21 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	55 Participants n=7 Participants	51 Participants n=5 Participants	49 Participants n=4 Participants	211 Participants n=21 Participants
Region of Enrollment United States	153 participants n=5 Participants	152 participants n=7 Participants	151 participants n=5 Participants	151 participants n=4 Participants	607 participants n=21 Participants

PRIMARY outcome

Timeframe: day 1 to day14

Population: Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation

change from baseline in the 12 hour reflective total nasal symptoms 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.

Outcome measures

Outcome measures
Measure	Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg n=153 Participants azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day	Azelastine Hcl 548 Mcg n=152 Participants azelastine Hcl nasal spray one spray per nostril two times a day	Fluticasone Propionate 200 Mcg n=151 Participants fluticasone propionate nasal spray one spray per nostril two times a day	Placebo n=151 Participants nasal spray
Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)	-5.3 units on a scale Standard Deviation 5.1	-3.3 units on a scale Standard Deviation 4.2	-3.8 units on a scale Standard Deviation 4.8	-2.2 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: day 1 to day 14

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

change from baseline in the 12 hour instantaneous total nasal symptoms 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.

Outcome measures

Outcome measures
Measure	Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg n=153 Participants azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day	Azelastine Hcl 548 Mcg n=152 Participants azelastine Hcl nasal spray one spray per nostril two times a day	Fluticasone Propionate 200 Mcg n=151 Participants fluticasone propionate nasal spray one spray per nostril two times a day	Placebo n=150 Participants nasal spray
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)	-4.4 units on a scale Standard Deviation 5.2	-3.0 units on a scale Standard Deviation 4.5	-3.5 units on a scale Standard Deviation 4.8	-1.7 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: day 1 to day 14

Population: Intent to Treat(ITT) population (18 years of age or older) who have had at least one post baseline efficacy evaluation

Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.

Outcome measures

Outcome measures
Measure	Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg n=135 Participants azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day	Azelastine Hcl 548 Mcg n=133 Participants azelastine Hcl nasal spray one spray per nostril two times a day	Fluticasone Propionate 200 Mcg n=132 Participants fluticasone propionate nasal spray one spray per nostril two times a day	Placebo n=126 Participants nasal spray
Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days	-1.6 units on a scale Standard Deviation 1.4	-1.2 units on a scale Standard Deviation 1.3	-1.4 units on a scale Standard Deviation 1.4	-1.0 units on a scale Standard Deviation 1.3

Adverse Events

Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Azelastine Hcl 548 Mcg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Fluticasone Propionate 200 Mcg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg n=153 participants at risk azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day	Azelastine Hcl 548 Mcg n=152 participants at risk azelastine Hcl nasal spray one spray per nostril two times a day	Fluticasone Propionate 200 Mcg n=151 participants at risk fluticasone propionate nasal spray one spray per nostril two times a day	Placebo n=151 participants at risk nasal spray
Gastrointestinal disorders dysgusia	7.2% 11/153 • Number of events 11	2.0% 3/152 • Number of events 3	0.00% 0/151	0.00% 0/151
Respiratory, thoracic and mediastinal disorders epistaxis	3.9% 6/153 • Number of events 6	2.6% 4/152 • Number of events 4	4.0% 6/151 • Number of events 6	3.3% 5/151 • Number of events 5
Nervous system disorders headache	2.6% 4/153 • Number of events 4	1.3% 2/152 • Number of events 2	4.0% 6/151 • Number of events 6	1.3% 2/151 • Number of events 2
General disorders pharyngolaryngeal pain	1.3% 2/153 • Number of events 2	0.66% 1/152 • Number of events 1	0.00% 0/151	0.66% 1/151 • Number of events 1
Skin and subcutaneous tissue disorders dry skin	1.3% 2/153 • Number of events 2	0.66% 1/152 • Number of events 1	0.00% 0/151	0.00% 0/151
Respiratory, thoracic and mediastinal disorders nasal discomfort	1.3% 2/153 • Number of events 2	0.00% 0/152	0.66% 1/151 • Number of events 1	0.00% 0/151
Gastrointestinal disorders nausea	0.65% 1/153 • Number of events 1	1.3% 2/152 • Number of events 2	0.00% 0/151	1.3% 2/151 • Number of events 2
Infections and infestations acute sinusitis	0.00% 0/153	1.3% 2/152 • Number of events 2	0.00% 0/151	0.00% 0/151

Additional Information

David Ginsberg, D.O.

Meda Pharmaceuticals

Phone: 7325642364

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