Trial Outcomes & Findings for A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies (NCT NCT00740792)

Last Updated: 2012-09-07

Results Overview

change from baseline in 12-hour reflective(how you felt over the previous 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.A greater negative score is suggestive of improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

776 participants

Primary outcome timeframe

day1 to 14 days

Results posted on

2012-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	MP29-02 azelastine HCl/fluticasone propionate	Azelastine HCL active comparator of azelastine HCl	Fluticasone Propionate active comparator of fluticasone propionate	Placebo placebo control
Overall Study STARTED	193	194	189	200
Overall Study COMPLETED	183	186	180	190
Overall Study NOT COMPLETED	10	8	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	MP29-02 azelastine HCl/fluticasone propionate	Azelastine HCL active comparator of azelastine HCl	Fluticasone Propionate active comparator of fluticasone propionate	Placebo placebo control
Overall Study Adverse Event	3	1	1	3
Overall Study Lack of Efficacy	1	1	0	3
Overall Study Lost to Follow-up	2	1	0	0
Overall Study Protocol Violation	0	1	0	2
Overall Study Withdrawal by Subject	1	1	0	0
Overall Study administrative	3	3	8	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MP29-02 n=193 Participants azelastine HCl/fluticasone propionate	Azelastine HCL n=194 Participants active comparator of azelastine HCl	Fluticasone Propionate n=189 Participants active comparator of fluticasone propionate	Placebo n=200 Participants placebo control	Total n=776 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	17 Participants n=4 Participants	55 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	176 Participants n=5 Participants	178 Participants n=7 Participants	172 Participants n=5 Participants	181 Participants n=4 Participants	707 Participants n=21 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants
Age Continuous	38.8 years STANDARD_DEVIATION 14.1 • n=5 Participants	38.2 years STANDARD_DEVIATION 13.5 • n=7 Participants	37.0 years STANDARD_DEVIATION 13.6 • n=5 Participants	37.2 years STANDARD_DEVIATION 13.0 • n=4 Participants	37.8 years STANDARD_DEVIATION 13.6 • n=21 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	128 Participants n=7 Participants	121 Participants n=5 Participants	119 Participants n=4 Participants	494 Participants n=21 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	66 Participants n=7 Participants	68 Participants n=5 Participants	81 Participants n=4 Participants	282 Participants n=21 Participants
Region of Enrollment United States	193 participants n=5 Participants	194 participants n=7 Participants	189 participants n=5 Participants	200 participants n=4 Participants	776 participants n=21 Participants

PRIMARY outcome

Timeframe: day1 to 14 days

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

Outcome measures

Outcome measures
Measure	MP29-02 n=193 Participants azelastine HCl/fluticasone propionate	Azelastine HCL n=194 Participants active comparator of azelastine HCl	Fluticasone Propionate n=189 Participants active comparator of fluticasone propionate	Placebo n=200 Participants placebo control
Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)	-5.5 units on a scale Standard Deviation 5.2	-4.5 units on a scale Standard Deviation 4.6	-4.6 units on a scale Standard Deviation 5.1	-3.0 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: day 1 to14

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 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.A greater negative value is suggestive of improvement.

Outcome measures

Outcome measures
Measure	MP29-02 n=193 Participants azelastine HCl/fluticasone propionate	Azelastine HCL n=193 Participants active comparator of azelastine HCl	Fluticasone Propionate n=188 Participants active comparator of fluticasone propionate	Placebo n=199 Participants placebo control
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)	-5.2 units on a scale Standard Deviation 5.3	-4.2 units on a scale Standard Deviation 4.6	-4.3 units on a scale Standard Deviation 5.2	-2.4 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: day 1 to day 14

Population: Intent to Treat (ITT) population (18 yrs of age and older) who have had one post baseline efficacy observation

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=176 Participants azelastine HCl/fluticasone propionate	Azelastine HCL n=172 Participants active comparator of azelastine HCl	Fluticasone Propionate n=169 Participants active comparator of fluticasone propionate	Placebo n=171 Participants placebo control
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	-1.7 units on a scale Standard Deviation 1.3	-1.4 units on a scale Standard Deviation 1.3	-1.5 units on a scale Standard Deviation 1.3	-1.0 units on a scale Standard Deviation 1.3

Adverse Events

MP29-02

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Azelastine HCL

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Fluticasone Propionate

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MP29-02 n=193 participants at risk azelastine HCl/fluticasone propionate	Azelastine HCL n=194 participants at risk active comparator of azelastine HCl	Fluticasone Propionate n=189 participants at risk active comparator of fluticasone propionate	Placebo n=200 participants at risk placebo control
Hepatobiliary disorders hepatitis C	0.52% 1/193 • Number of events 1	0.00% 0/194	0.00% 0/189	0.00% 0/200

Other adverse events

Other adverse events
Measure	MP29-02 n=193 participants at risk azelastine HCl/fluticasone propionate	Azelastine HCL n=194 participants at risk active comparator of azelastine HCl	Fluticasone Propionate n=189 participants at risk active comparator of fluticasone propionate	Placebo n=200 participants at risk placebo control
Nervous system disorders headache	3.1% 6/193 • Number of events 6	2.1% 4/194 • Number of events 4	2.6% 5/189 • Number of events 5	1.0% 2/200 • Number of events 2
Gastrointestinal disorders dysgeusia	2.1% 4/193 • Number of events 4	7.2% 14/194 • Number of events 14	0.53% 1/189 • Number of events 1	0.50% 1/200 • Number of events 1
Respiratory, thoracic and mediastinal disorders epistaxis	1.6% 3/193 • Number of events 3	2.1% 4/194 • Number of events 4	1.6% 3/189 • Number of events 5	2.5% 5/200 • Number of events 5
General disorders mucosal erosion	1.6% 3/193 • Number of events 3	0.00% 0/194	0.00% 0/189	0.00% 0/200
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	1.0% 2/193 • Number of events 2	2.1% 4/194 • Number of events 4	2.6% 5/189 • Number of events 5	1.0% 2/200 • Number of events 2
Respiratory, thoracic and mediastinal disorders cough	1.0% 2/193 • Number of events 2	0.52% 1/194 • Number of events 1	0.00% 0/189	0.00% 0/200
Infections and infestations upper respiratory tract infection	0.52% 1/193 • Number of events 1	1.0% 2/194 • Number of events 2	0.53% 1/189 • Number of events 1	0.50% 1/200 • Number of events 1
Respiratory, thoracic and mediastinal disorders nasal discomfort	0.52% 1/193 • Number of events 1	1.0% 2/194 • Number of events 2	0.00% 0/189	0.00% 0/200
Infections and infestations nasopharyingitis	0.52% 1/193 • Number of events 1	1.0% 2/194 • Number of events 2	0.00% 0/189	0.00% 0/200
Gastrointestinal disorders nausea	0.52% 1/193 • Number of events 1	0.00% 0/194	0.00% 0/189	1.0% 2/200 • Number of events 2

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