Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies (NCT NCT00651118)

Results Overview

change from baseline in 12-hour reflective(how did you feel in the last 12 hours) 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.The more negative value the better the result.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

832 participants

Primary outcome timeframe

days 1 to 14

Results posted on

2012-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	MP29-02 MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray	Fluticasone Propionate fluticasone propionate nasal spray	Azelastine HCl azelastine HCl nasal spray nasal spray	Placebo placebo nasal spray
Overall Study STARTED	207	207	208	210
Overall Study COMPLETED	198	200	197	203
Overall Study NOT COMPLETED	9	7	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	MP29-02 MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray	Fluticasone Propionate fluticasone propionate nasal spray	Azelastine HCl azelastine HCl nasal spray nasal spray	Placebo placebo nasal spray
Overall Study Adverse Event	4	0	1	1
Overall Study Protocol Violation	2	2	6	2
Overall Study Lost to Follow-up	2	0	1	2
Overall Study administrative	1	4	2	1
Overall Study Withdrawal by Subject	0	1	1	1

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=207 Participants MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray	Fluticasone Propionate n=207 Participants fluticasone propionate nasal spray	Azelastine HCl n=208 Participants azelastine HCl nasal spray nasal spray	Placebo n=210 Participants placebo nasal spray	Total n=832 Participants Total of all reporting groups
Age, Categorical <=18 years	19 Participants n=113 Participants	15 Participants n=163 Participants	28 Participants n=160 Participants	36 Participants n=483 Participants	98 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	183 Participants n=113 Participants	185 Participants n=163 Participants	172 Participants n=160 Participants	166 Participants n=483 Participants	706 Participants n=36 Participants
Age, Categorical >=65 years	5 Participants n=113 Participants	7 Participants n=163 Participants	8 Participants n=160 Participants	8 Participants n=483 Participants	28 Participants n=36 Participants
Age Continuous	37.3 years STANDARD_DEVIATION 14.1 • n=113 Participants	38.6 years STANDARD_DEVIATION 14.1 • n=163 Participants	36.2 years STANDARD_DEVIATION 14.6 • n=160 Participants	37.3 years STANDARD_DEVIATION 16.0 • n=483 Participants	37.3 years STANDARD_DEVIATION 14.7 • n=36 Participants
Sex: Female, Male Female	142 Participants n=113 Participants	127 Participants n=163 Participants	130 Participants n=160 Participants	133 Participants n=483 Participants	532 Participants n=36 Participants
Sex: Female, Male Male	65 Participants n=113 Participants	80 Participants n=163 Participants	78 Participants n=160 Participants	77 Participants n=483 Participants	300 Participants n=36 Participants
Region of Enrollment United States	207 participants n=113 Participants	207 participants n=163 Participants	208 participants n=160 Participants	210 participants n=483 Participants	832 participants n=36 Participants

PRIMARY outcome

Timeframe: days 1 to 14

Population: intent to treat population (ITT)- must have had at least one post baseline efficacy assessment

change from baseline in 12-hour reflective(how did you feel in the last 12 hours) 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.The more negative value the better the result.

Outcome measures

Outcome measures
Measure	MP29-02 n=207 Participants MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray	Fluticasone Propionate n=207 Participants fluticasone propionate nasal spray	Azelastine HCl n=208 Participants azelastine HCl nasal spray nasal spray	Placebo n=209 Participants placebo nasal spray
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)	-5.6 units on a scale Standard Deviation 5.2	-4.7 units on a scale Standard Deviation 4.7	-4.2 units on a scale Standard Deviation 4.6	-2.9 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: day 1 to day 14

Population: intent to treat population (ITT)- must have had at least one post baseline efficacy assessment

change from baseline in 12-hour instantaneous ( how do you feel now) 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.The more negative the value the better the result.

Outcome measures

Outcome measures
Measure	MP29-02 n=207 Participants MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray	Fluticasone Propionate n=207 Participants fluticasone propionate nasal spray	Azelastine HCl n=208 Participants azelastine HCl nasal spray nasal spray	Placebo n=209 Participants placebo nasal spray
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)	-5.2 units on a scale Standard Deviation 5.3	-4.5 units on a scale Standard Deviation 4.7	-4.0 units on a scale Standard Deviation 4.7	-2.6 units on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: day 1 to day 14

Population: intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment

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.The more negative the value the better the result.

Outcome measures

Outcome measures
Measure	MP29-02 n=176 Participants MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray	Fluticasone Propionate n=184 Participants fluticasone propionate nasal spray	Azelastine HCl n=174 Participants azelastine HCl nasal spray nasal spray	Placebo n=169 Participants placebo nasal spray
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days	-1.6 units on a scale Standard Deviation 1.4	-1.6 units on a scale Standard Deviation 1.2	-1.4 units on a scale Standard Deviation 1.1	-0.9 units on a scale Standard Deviation 1.1

Adverse Events

MP29-02

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Fluticasone Propionate

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Azelastine HCl

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MP29-02 n=207 participants at risk MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray	Fluticasone Propionate n=207 participants at risk fluticasone propionate nasal spray	Azelastine HCl n=208 participants at risk azelastine HCl nasal spray nasal spray	Placebo n=210 participants at risk placebo nasal spray
Gastrointestinal disorders dysgusia	2.4% 5/207 • Number of events 5	0.97% 2/207 • Number of events 2	3.4% 7/208 • Number of events 7	0.48% 1/210 • Number of events 1
Respiratory, thoracic and mediastinal disorders epistaxis	0.97% 2/207 • Number of events 2	2.4% 5/207 • Number of events 5	1.9% 4/208 • Number of events 4	0.95% 2/210 • Number of events 2
Nervous system disorders headache	0.48% 1/207 • Number of events 1	2.4% 5/207 • Number of events 5	0.48% 1/208 • Number of events 1	1.4% 3/210 • Number of events 3
Respiratory, thoracic and mediastinal disorders nasal discomfort	0.97% 2/207 • Number of events 2	0.97% 2/207 • Number of events 2	1.9% 4/208 • Number of events 4	0.00% 0/210
Gastrointestinal disorders nausea	0.48% 1/207 • Number of events 1	0.97% 2/207 • Number of events 2	0.48% 1/208 • Number of events 1	0.00% 0/210
Respiratory, thoracic and mediastinal disorders sneezing	0.48% 1/207 • Number of events 1	0.00% 0/207	0.96% 2/208 • Number of events 2	0.48% 1/210 • Number of events 1

Additional Information

David Ginsberg,..

Meda Pharmaceutical

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