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

This study has been completed.

Sponsor:

Information provided by:

Meda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00660829

First received: April 14, 2008

Last updated: February 19, 2010

Last verified: January 2010

History of Changes

Results First Received: September 30, 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: Placebo Drug: 0.15% Azelastine Hydrochloride

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 December 13, 2007 Last Observation February 21, 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
Astepro 0.15%	0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days

Participant Flow: Overall Study

	Placebo	Astepro 0.15%
STARTED	268 ^[1]	268 ^[1]
COMPLETED	250	249
NOT COMPLETED	18	19
Adverse Event	3	4
Lack of Efficacy	2	3
Non-Compliance	0	4
Withdrawal by Subject	1	2
Lost to Follow-up	3	2
Other	9	4

[1]	2 subjects were randomized in error

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
Astepro 0.15%	0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
Total	Total of all reporting groups

Baseline Measures

	Placebo	Astepro 0.15%	Total
Number of Participants [units: participants]	266	266	532
Age ^[1] [units: participants]
<=18 years	14	20	34
Between 18 and 65 years	241	230	471
>=65 years	11	16	27
Age ^[1] [units: years] Mean ± Standard Deviation	39.5 ± 14.41	40.9 ± 14.51	40.2 ± 14.46
Gender ^[1] [units: participants]
Female	171	175	346
Male	95	91	186
Region of Enrollment ^[1] [units: participants]
United States	266	266	532

[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 (TNSS) (AM and PM Combined)at 14 Days [ Time Frame: baseline and 14 days ]

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2. Secondary:

Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo. [ Time Frame: basline and 14 days ]

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Measure Type	Secondary
Measure Title	Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.
Measure Description	End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. 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 baseline as a covariate.
Time Frame	basline 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/2 sprays per nostril once daily for 14 days
Astepro 0.15%	0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days

Measured Values

	Placebo	Astepro 0.15%
Number of Participants Analyzed [units: participants]	266	266
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo. [units: Scores on a scale] Least Squares Mean ± Standard Error	-0.66 ± 1.859	-1.38 ± 2.103

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

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-0.7444
Standard Error of the mean	± 0.1677
95% Confidence Interval	( -1.07 to -0.42 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[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 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days [ Time Frame: baseline and 14-days ]

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4. Secondary:

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

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5. Secondary:

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: baseline and 14 Days ]

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6. Secondary:

Change From Baseline on Direct Visual Nasal Exams at 14 Days [ Time Frame: baseline and 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
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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
ClinicalTrials.gov Identifier:	NCT00660829 History of Changes
Other Study ID Numbers:	MP440
Study First Received:	April 14, 2008
Results First Received:	September 30, 2009
Last Updated:	February 19, 2010
Health Authority:	United States: Food and Drug Administration

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