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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Meda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00740792

First received: August 22, 2008

Last updated: August 7, 2012

Last verified: August 2012

History of Changes

Results First Received: May 15, 2012

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: azelastine HCl/fluticasone propionate Drug: azelastine Hcl Drug: fluticasone propionate 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
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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
MP29-02	azelastine HCl/fluticasone propionate
Azelastine HCL	active comparator of azelastine HCl
Fluticasone Propionate	active comparator of fluticasone propionate
Placebo	placebo control

Participant Flow: Overall Study

	MP29-02	Azelastine HCL	Fluticasone Propionate	Placebo
STARTED	193	194	189	200
COMPLETED	183	186	180	190
NOT COMPLETED	10	8	9	10
Adverse Event	3	1	1	3
Lack of Efficacy	1	1	0	3
Lost to Follow-up	2	1	0	0
Protocol Violation	0	1	0	2
Withdrawal by Subject	1	1	0	0
administrative	3	3	8	2

Baseline Characteristics

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Reporting Groups

	Description
MP29-02	azelastine HCl/fluticasone propionate
Azelastine HCL	active comparator of azelastine HCl
Fluticasone Propionate	active comparator of fluticasone propionate
Placebo	placebo control
Total	Total of all reporting groups

Baseline Measures

	MP29-02	Azelastine HCL	Fluticasone Propionate	Placebo	Total
Number of Participants [units: participants]	193	194	189	200	776
Age [units: participants]
<=18 years	12	12	14	17	55
Between 18 and 65 years	176	178	172	181	707
>=65 years	5	4	3	2	14
Age [units: years] Mean ± Standard Deviation	38.8 ± 14.1	38.2 ± 13.5	37.0 ± 13.6	37.2 ± 13.0	37.8 ± 13.6
Gender [units: participants]
Female	126	128	121	119	494
Male	67	66	68	81	282
Region of Enrollment [units: participants]
United States	193	194	189	200	776

Outcome Measures

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1. Primary:

Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: day1 to 14 days ]

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2. Secondary:

Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: day 1 to14 ]

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3. Secondary:

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: day 1 to day 14 ]

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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:

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)

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: David Ginsberg,D.O.
Organization: Meda Pharmaceuticals
phone: 7325642364
e-mail: david.ginsberg@meda.us

No publications provided

Responsible Party:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00740792 History of Changes
Other Study ID Numbers:	MP4004
Study First Received:	August 22, 2008
Results First Received:	May 15, 2012
Last Updated:	August 7, 2012
Health Authority:	United States: Food and Drug Administration

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