Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

This study has been completed.

Sponsor:

Information provided by:

Meda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00783432

First received: October 30, 2008

Last updated: October 1, 2009

Last verified: October 2009

History of Changes

Results First Received: December 29, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Chronic Allergic Rhinitis Nonallergic Rhinitis
Interventions:	Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride) Drug: Astelin Nasal Spray (0.1% 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 24 July 2006 and last observation 28 Dec 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects participated in a one-week screening period to identify appropriate subjects based on symptom scores

Reporting Groups

	Description
Astepro Nasal Spray	(0.1% azelastine hydrochloride)
Astelin Nasal Spray	(0.1% azelastine hydrochloride)

Participant Flow: Overall Study

	Astepro Nasal Spray	Astelin Nasal Spray
STARTED	430 ^[1]	432 ^[1]
COMPLETED	345	354
NOT COMPLETED	85	78
Adverse Event	22	17
Lack of Efficacy	20	21
Lost to Follow-up	11	6
Withdrawal by Subject	23	20
subject moved	3	5
Protocol Violation	6	9

[1]	This includes 2 subjects that received a randomization number but did not receive study drug

Baseline Characteristics

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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.
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Reporting Groups

	Description
Astepro Nasal Spray	(0.1% azelastine hydrochloride)
Astelin Nasal Spray	(0.1% azelastine hydrochloride)
Total	Total of all reporting groups

Baseline Measures

	Astepro Nasal Spray	Astelin Nasal Spray	Total
Number of Participants [units: participants]	428	430	858
Age [units: participants]
<=18 years	11	10	21
Between 18 and 65 years	389	391	780
>=65 years	28	29	57
Age [units: years] Mean (Standard Deviation)	41.2 (14.95)	41.3 (15.12)	41.2 (15.03)
Gender [units: participants]
Female	221	236	457
Male	207	194	401
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0
Asian	8	16	24
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	6	4	10
White	410	405	815
More than one race	0	0	0
Unknown or Not Reported	3	5	8
Region of Enrollment [units: participants]
Australia	40	39	79
Europe	388	391	779
Duration of Rhinitis [units: years] Mean (Standard Deviation)	10.5 (11.04)	11.3 (10.85)	10.9 (10.95)
Total Nasal Symptom Score (AM + PM) ^[1] [units: units on a scale (0-3)] Mean (Standard Deviation)	9.69 (4.506)	9.96 (4.725)	9.82 (4.617)

[1]	TNSS scale: 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3 = severe symptoms scored twice daily such that the maximum daily score is 24.

Outcome Measures

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1. Primary:

Number of Participants Reporting Adverse Events [ Time Frame: 12 months ]

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2. Primary:

Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. [ Time Frame: baseline and 12 months/ET ]

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3. Secondary:

Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. [ Time Frame: baseline, months 1,3,6,9 and 12/or early termination ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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.

Results Point of Contact:

Name/Title: William Wheeler, PhD
Organization: Meda Pharmaceuticals
phone: 732-564-2351
e-mail: wwheeler@medapharma.us

Responsible Party:	Harry Sacks, MD, Vice President, Medical and Scientific Affairs
ClinicalTrials.gov Identifier:	NCT00783432 History of Changes
Other Study ID Numbers:	MP432
Study First Received:	October 30, 2008
Results First Received:	December 29, 2008
Last Updated:	October 1, 2009
Health Authority:	Bulgaria: Ministry of Health Slovakia: State Institute for Drug Control Australia: Department of Health and Ageing Therapeutic Goods Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United Kingdom: Medicines and Healthcare Products Regulatory Agency

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