Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00305487

Collaborator

(none)

660

Enrollment

Locations

Duration (Months)

9.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

Condition or Disease	Intervention/Treatment	Phase
Hay Fever Seasonal Allergic Rhinitis	Drug: Ciclesonide nasal spray	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment []

Secondary Outcome Measures

Physician assessment of nasal symptoms score at endpoint []
average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment []
safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main Inclusion Criteria:

Written informed consent
General good health other than seasonal allergic rhinitis
Positive standard skin prick test

Main Exclusion Criteria:

Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
Participation in any investigational drug trial within the 30 days preceding the Screening Visit
A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
Use of any prohibited concomitant medications
Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
Study participation by more than one patient from the same household

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altana Pharma/Nycomed	Birmingham	Alabama	United States	35235
2	Altana Pharma/Nycomed	Hot Springs	Arkansas	United States	71913
3	Altana Pharma/Nycomed	Costa Mesa	California	United States	92626
4	Altana Pharma/Nycomed	Huntington Beach	California	United States	92647
5	Altana Pharma/Nycomed	Long Beach	California	United States	90806
6	Altana Pharma/Nycomed	Los Alamitos	California	United States	90720
7	Altana Pharma/Nycomed	Mission Viejo	California	United States	92691
8	Altana Pharma/Nycomed	Orange	California	United States	92868
9	Altana Pharma/Nycomed	Roseville	California	United States	95678
10	Altana Pharma/Nycomed	San Diego	California	United States	92120
11	Altana Pharma/Nycomed	San Diego	California	United States	92123
12	Altana Pharma/Nycomed	San Jose	California	United States	95117
13	Altana Pharma/Nycomed	Stockton	California	United States	95207
14	Altana Pharma/Nycomed	Colorado Springs	Colorado	United States	80907
15	Altana Pharma/Nycomed	Denver	Colorado	United States	80230
16	Altana Pharma/Nycomed	Englewood	Colorado	United States	80112
17	Altana Pharma/Nycomed	Lakewood, CO	Colorado	United States	80401
18	Altana Pharma/Nycomed	Atlanta	Georgia	United States	30342
19	Altana Pharma/Nycomed	Gainesville	Georgia	United States	30501
20	Altana Pharma/Nycomed	Savannah	Georgia	United States	31406
21	Altana Pharma/Nycomed	Woodstock, GA	Georgia	United States	30188
22	Altana Pharma/Nycomed	Normal	Illinois	United States	61761
23	Altana Pharma/Nycomed	Indianapolis	Indiana	United States	46208
24	Altana Pharma/Nycomed	Overland Park	Kansas	United States	66211
25	Altana Pharma/Nycomed	Louisville, KY	Kentucky	United States	40215
26	Altana Pharma/Nycomed	Metairie	Louisiana	United States	70006
27	Altana Pharma/Nycomed	Shreveport	Louisiana	United States	71105
28	Altana Pharma/Nycomed	Bethesda	Maryland	United States	20814
29	Altana Pharma/Nycomed	North Dartmouth	Massachusetts	United States	02747
30	Altana Pharma/Nycomed	Minneapolis	Minnesota	United States	55402
31	Altana Pharma/Nycomed	Jefferson City	Missouri	United States	65109
32	Altana Pharma/Nycomed	Rolla	Missouri	United States	65401
33	Altana Pharma/Nycomed	St. Louis	Missouri	United States	63141
34	Altana Pharma/Nycomed	Lincoln, NE	Nebraska	United States	68505
35	Altana Pharma/Nycomed	Papillion	Nebraska	United States	68046
36	Altana Pharma/Nycomed	Brick	New Jersey	United States	08724
37	Altana Pharma/Nycomed	Forked River	New Jersey	United States	08731
38	Altana Pharma/Nycomed	Red Bank	New Jersey	United States	07701
39	Altana Pharma/Nycomed	Skillman	New Jersey	United States	08558
40	Altana Pharma/Nycomed	Warren	New Jersey	United States	07059
41	Altana Pharma/Nycomed	Rochester, NY	New York	United States	14618
42	Altana Pharma/Nycomed	Rockville Centre	New York	United States	11570
43	Altana Pharma/Nycomed	Raleigh	North Carolina	United States	27607
44	Altana Pharma/Nycomed	Cincinnati, OH	Ohio	United States	45231
45	Altana Pharma/Nycomed	Cincinnati	Ohio	United States	45219
46	Altana Pharma/Nycomed	Ashland	Oregon	United States	97520
47	Altana Pharma/Nycomed	Lake Oswego	Oregon	United States	97035
48	Altana Pharma/Nycomed	Medford, OR	Oregon	United States	97504
49	Altana Pharma/Nycomed	Portland	Oregon	United States	97213
50	Altana Pharma/Nycomed	Blue Bell	Pennsylvania	United States	19422
51	Altana Pharma/Nycomed	Eerie	Pennsylvania	United States	16506
52	Altana Pharma/Nycomed	Pittsburgh	Pennsylvania	United States	15202
53	Altana Pharma/Nycomed	Pittsburgh	Pennsylvania	United States	15241
54	Altana Pharma/Nycomed	Upland	Pennsylvania	United States	19013
55	Altana Pharma/Nycomed	Charleston, SC	South Carolina	United States	29407
56	Altana Pharma/Nycomed	Charleston	South Carolina	United States	29414
57	Altana Pharma/Nycomed	Germantown	Tennessee	United States	38138
58	Altana Pharma/Nycomed	Jackson	Tennessee	United States	38301
59	Altana Pharma/Nycomed	Austin	Texas	United States	78731
60	Altana Pharma/Nycomed	Austin	Texas	United States	78750
61	Altana Pharma/Nycomed	Dallas	Texas	United States	75231
62	Altana Pharma/Nycomed	El Paso	Texas	United States	79925
63	Altana Pharma/Nycomed	Kerrville	Texas	United States	78028
64	Altana Pharma/Nycomed	New Braunfels	Texas	United States	78130
65	Altana Pharma/Nycomed	San Antonio	Texas	United States	78229
66	Altana Pharma/Nycomed	Salt Lake City	Utah	United States	84037
67	Altana Pharma/Nycomed	South Burlington	Vermont	United States	05403
68	Altana Pharma/Nycomed	Burke	Virginia	United States	22015
69	Altana Pharma/Nycomed	Charlottesville	Virginia	United States	22911
70	Altana Pharma/Nycomed	Richmond	Virginia	United States	23226
71	Altana Pharma/Nycomed	Milwaukee	Wisconsin	United States	53209