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

This study has been completed.

Study NCT00824473 Information provided by Meda Pharmaceuticals

First Received on January 14, 2009. Last Updated on February 19, 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: 30 Dec 2008 Last observation: 13 Feb 2009

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/2 sprays per nostril once a day for 14 days
Astepro 0.15%	0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days

Participant Flow: Overall Study

	Placebo	Astepro 0.15%
STARTED	255 ^[1]	251
COMPLETED	240	238
NOT COMPLETED	15	13
Adverse Event	4	5
Lack of Efficacy	2	2
Protocol Violation	2	0
Non-Compliance	4	2
Withdrawal by Subject	2	3
Other	1	1

[1]	1 subject was randomized in error

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
Astepro 0.15%	0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days

Baseline Measures

	Placebo	Astepro 0.15%	Total
Number of Participants [units: participants]	254	251	505
Age ^[1] [units: participants]
<=18 years	27	24	51
Between 18 and 65 years	220	218	438
>=65 years	7	9	16
Age ^[1] [units: years] Mean ± Standard Deviation	38.5 ± 14.59	38.0 ± 14.40	38.2 ± 14.48
Gender ^[1] [units: participants]
Female	150	157	307
Male	104	94	198
Region of Enrollment ^[1] [units: participants]
United States	254	251	505

[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 (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 Sscore (AM) for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline to 14 Days ]

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3. Secondary:

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

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4. Secondary:

Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) [ Time Frame: baseline to14 Days ]

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5. Secondary:

Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older [ Time Frame: 14 Days ]

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6. Secondary:

Change From Baseline on Direct Visual Nasal Exams to 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, Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00824473 History of Changes
Other Study ID Numbers:	MP443
Study First Received:	January 14, 2009
Results First Received:	September 30, 2009
Last Updated:	February 19, 2010
Health Authority:	United States: Food and Drug Administration