Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00252785

Collaborator

(none)

340

Enrollment

Locations

Duration (Months)

7.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Budesonide/Formoterol Drug: Budesonide Drug: Theophylline	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

An 8-week, Randomised, Double Blind, Parallel-group, Multi-centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Patients With Asthma

Study Start Date :

Oct 1, 2005

Actual Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

Morning peak expiratory flow (mPEF) []

Secondary Outcome Measures

Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries []
Forced expiratory volume in one second (FEV1) []
Safety: []
Adverse events (nature, incidence and severity) []
Haematology, clinical chemistry and urinalysis []
12-lead ECGs, blood pressure, pulse rate []
- all variables assessed over the 8 week treatment period []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
Prescribed daily use of an IGCS for >=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1

Exclusion Criteria:

Any significant disease or disorder that may jeopardize the safety of the patient
Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1

Additional inclusion and exclusion criteria will be evaluated by the Investigator

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Komaki	Aichi	Japan
2	Research Site	Seto	Aichi	Japan
3	Research Site	Asahi	Chiba	Japan
4	Research Site	Noda	Chiba	Japan
5	Research Site	Touon	Ehime	Japan
6	Research Site	Mizumaki	Fukuoka	Japan
7	Research Site	Isesaki	Gunma	Japan
8	Research Site	Maebashi	Gunma	Japan
9	Research Site	Ora	Gunma	Japan
10	Research Site	Ota	Gunma	Japan
11	Research Site	Chitose	Hokkaido	Japan
12	Research Site	Kitahiroshima	Hokkaido	Japan
13	Research Site	Obihiro	Hokkaido	Japan
14	Research Site	Sapporo	Hokkaido	Japan
15	Research Site	Tomakomai	Hokkaido	Japan
16	Research Site	Morioka	Iwate	Japan
17	Research Site	Takamatsu	Kagawa	Japan
18	Research Site	Sendai	Miyagi	Japan
19	Research Site	Beppu	Ohita	Japan
20	Research Site	Tsukubo	Okayama	Japan
21	Research Site	Kishiwada	Osaka	Japan
22	Research Site	Oskasayama	Osaka	Japan
23	Research Site	Takatsuiki	Osaka	Japan
24	Research Site	Koshigaya	Saitama	Japan
25	Research Site	Minamisaitama	Saitama	Japan
26	Research Site	Arakawa	Tokyo	Japan
27	Research Site	Chiyoda	Tokyo	Japan
28	Research Site	Itabashi	Tokyo	Japan
29	Research Site	Kodaira	Tokyo	Japan
30	Research Site	Nakano-ku	Tokyo	Japan
31	Research Site	Ota-ku	Tokyo	Japan
32	Research Site	Shinagawa-ku	Tokyo	Japan
33	Research Site	Sumida	Tokyo	Japan
34	Research Site	Ube	Yamaguchi	Japan
35	Research Site	Gifu		Japan
36	Research Site	Hiroshima		Japan
37	Research Site	Kagoshima		Japan
38	Research Site	Kyoto		Japan
39	Research Site	Oita		Japan
40	Research Site	Okayama		Japan
41	Research Site	Osaka		Japan
42	Research Site	Tochigi		Japan
43	Research Site	Toyama		Japan