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
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252785
First received: November 11, 2005
Last updated: January 21, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Budesonide/Formoterol Drug: Budesonide Drug: Theophylline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Theophylline
Aminophylline dihydrate
Formoterol fumarate
Budesonide
Formoterol
Arformoterol Tartrate
U.S. FDA Resources
Further study details as provided by AstraZeneca:
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
| Estimated Enrollment: | 340 |
| Study Start Date: | October 2005 |
| Study Completion Date: | November 2006 |
Intervention Details:
-
Drug: Budesonide/Formoterol
Other Name: Symbicort
Drug: Budesonide
Drug: Theophylline
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252785
Locations
| 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 | |
| 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 | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00252785 History of Changes |
| Other Study ID Numbers: | D5890C00010 |
| Study First Received: | November 11, 2005 |
| Last Updated: | January 21, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by AstraZeneca:
|
Asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Theophylline Budesonide Formoterol Symbicort Purinergic P1 Receptor Antagonists Purinergic Antagonists |
Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013