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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Budesonide/Formoterol (Drug); Budesonide (Drug); Theophylline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

Summary

The primary objective of this study is to confirm the efficacy (superiority) of Symbicort Turbuhaler 160/4. 5 g twice daily for 8 weeks in comparison to Pulmicort Turbuhaler 200 g twice daily + Theolong tablet 200 mg twice daily.

Clinical Details

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 g Twice Daily and Pulmicort Turbuhaler 200 g Twice Daily + Theolong Tablet 200 mg Twice Daily in Japanese Patients With Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Morning peak expiratory flow (mPEF)

Secondary outcome:

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

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Gifu, Japan

Research Site, Hiroshima, Japan

Research Site, Kagoshima, Japan

Research Site, Kyoto, Japan

Research Site, Oita, Japan

Research Site, Okayama, Japan

Research Site, Osaka, Japan

Research Site, Tochigi, Japan

Research Site, Toyama, Japan

Research Site, Komaki, Aichi, Japan

Research Site, Seto, Aichi, Japan

Research Site, Asahi, Chiba, Japan

Research Site, Noda, Chiba, Japan

Research Site, Touon, Ehime, Japan

Research Site, Mizumaki, Fukuoka, Japan

Research Site, Isesaki, Gunma, Japan

Research Site, Maebashi, Gunma, Japan

Research Site, Ora, Gunma, Japan

Research Site, Ota, Gunma, Japan

Research Site, Chitose, Hokkaido, Japan

Research Site, Kitahiroshima, Hokkaido, Japan

Research Site, Obihiro, Hokkaido, Japan

Research Site, Sapporo, Hokkaido, Japan

Research Site, Tomakomai, Hokkaido, Japan

Research Site, Morioka, Iwate, Japan

Research Site, Takamatsu, Kagawa, Japan

Research Site, Sendai, Miyagi, Japan

Research Site, Beppu, Ohita, Japan

Research Site, Tsukubo, Okayama, Japan

Research Site, Kishiwada, Osaka, Japan

Research Site, Oskasayama, Osaka, Japan

Research Site, Takatsuiki, Osaka, Japan

Research Site, Koshigaya, Saitama, Japan

Research Site, Minamisaitama, Saitama, Japan

Research Site, Arakawa, Tokyo, Japan

Research Site, Chiyoda, Tokyo, Japan

Research Site, Itabashi, Tokyo, Japan

Research Site, Kodaira, Tokyo, Japan

Research Site, Nakano-ku, Tokyo, Japan

Research Site, Ota-ku, Tokyo, Japan

Research Site, Shinagawa-ku, Tokyo, Japan

Research Site, Sumida, Tokyo, Japan

Research Site, Ube, Yamaguchi, Japan

Additional Information

Starting date: October 2005
Last updated: January 21, 2011

Page last updated: August 23, 2015

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