A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

This study has been completed.

Sponsor:

Information provided by:

Meda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00720278

First received: July 21, 2008

Last updated: February 19, 2010

Last verified: February 2010

History of Changes

Results First Received: September 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Seasonal Allergic Rhinitis
Interventions:	Drug: 0.15% azelastine hydrochloride 1644 mcg daily Drug: 0.1% azelastine hydrochloride 1096 mcg daily Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First observation: 14 Aug 2007 Last observation: 19 Nov 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.

Reporting Groups

	Description
Placebo	Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.1%	0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.15%	0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days

Participant Flow: Overall Study

	Placebo	Astepro 0.1%	Astepro 0.15%
STARTED	178 ^[1]	170 ^[1]	178 ^[1]
COMPLETED	171	166	172
NOT COMPLETED	7	4	6
Adverse Event	5	3	4
Withdrawal by Subject	0	1	0
Lost to Follow-up	0	0	1
Non-compliance	1	0	0
eligibility criteria violation	1	0	1

[1]	1 subject was randomized in error

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.1%	0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.15%	0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Total	Total of all reporting groups

Baseline Measures

	Placebo	Astepro 0.1%	Astepro 0.15%	Total
Number of Participants [units: participants]	177	169	177	523
Age ^[1] [units: participants]
<=18 years	24	16	16	56
Between 18 and 65 years	148	151	156	455
>=65 years	5	2	5	12
Age ^[1] [units: years] Mean ± Standard Deviation	36.9 ± 14.27	35.4 ± 13.74	37.7 ± 14.64	36.7 ± 14.23
Gender ^[1] [units: participants]
Female	116	111	107	334
Male	61	58	70	189
Region of Enrollment ^[1] [units: participants]
United States	177	169	177	523

[1]	Number of participants based on ITT population

Outcome Measures

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1. Primary:

Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 days ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 Days ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
Measure Description	instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Time Frame	baseline and 14 Days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo	Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.1%	0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
Astepro 0.15%	0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days

Measured Values

	Placebo	Astepro 0.1%	Astepro 0.15%
Number of Participants Analyzed [units: participants]	171	166	172
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo [units: total nasal symptom score] Least Squares Mean ± Standard Deviation
Baseline symptom score	16.56 ± 3.962	17.22 ± 3.836	16.43 ± 3.998
Overall change from baseline	-1.96 ± 4.313	-3.74 ± 4.796	-4.63 ± 5.261

Statistical Analysis 1 for Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo

Groups ^[1]	Placebo vs. Astepro 0.1%
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-1.78
Standard Deviation	± 0.479
95% Confidence Interval	( -2.72 to -0.84 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Change in baseline to Day 14
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo

Groups ^[1]	Placebo vs. Astepro 0.15%
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-2.668
Standard Deviation	± 0.4735
95% Confidence Interval	( -3.60 to -1.74 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Change in baseline to Day 14
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 days ]

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4. Secondary:

Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older [ Time Frame: baseline and 14 days ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline on Direct Visual Nasal Exams [ Time Frame: 14 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: For multicenter studies, joint publication is required to assure that the initial publication is based on all data from all sites and investigators participating in these studies agree not to present data gathered individually or by subgroup centers before the initial publication unless jointly agreed by all other investigators and the sponsor. authorship will be determined by mutual agreement.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: William Wheeler, PhD
Organization: Meda Pharmaceuticals
phone: 732-564-2393
e-mail: WWheeler@medapharma.us

No publications provided

Responsible Party:	Harry Sacks, MD Vice President, Medical and Scientific Affairs, Med Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00720278 History of Changes
Other Study ID Numbers:	MP438
Study First Received:	July 21, 2008
Results First Received:	September 23, 2009
Last Updated:	February 19, 2010
Health Authority:	United States: Food and Drug Administration

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