Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01069289 | Completed Phase 3 Results

• 1 other identifier: D589DC00007
• Study Type: interventional
• Target: 1,293
• Locations: 9 countries
• Sites: 119

Brief Summary

The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Symbicort; Oxis; Chronic Obstructive Pulmonary Disease; COPD; Efficacy

Outcome Measures

Primary Outcomes (1)

• Pre-dose Forced Expiratory Volume in One Second (FEV1)

  The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group

  Before randomization, 0, 4, 8 and 12 weeks after randomization

Secondary Outcomes (16)

• 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)

  Before randomization, 0, 4, 8 and 12 weeks after randomization

• Pre-dose Forced Vital Capacity (FVC)

  Before randomization, 0, 4, 8 and 12 weeks after randomization

• 1 Hour Post-dose Forced Vital Capacity (FVC)

  Before randomization, 0, 4, 8 and 12 weeks after randomization

• Percentage of Participants With Exacerbations

  Daily during 12-week randomization treatment

• Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

  Daily during 12-week randomization treatment

Study Arms (2)

1

EXPERIMENTAL

Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily

Drug: Budesonide/formoterol (Symbicort Turbuhaler)

2

ACTIVE COMPARATOR

Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily

Drug: Formoterol (Oxis Turbuhaler)

Interventions

Budesonide/formoterol (Symbicort Turbuhaler) DRUG

2x160/4.5 microgram, inhalation, twice daily, 12 weeks

Also known as: Symbicort Turbuhaler

1

Formoterol (Oxis Turbuhaler) DRUG

2 X 4.5 microgram, inhalation, twice daily, 12 weeks

Also known as: Oxis Turbuhaler

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
• Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
• A smoking history of at least 10 pack years

You may not qualify if:

• History and/or current clinical diagnosis of asthma
• History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (119)

Research Site

Bangalore, Karnataka, India

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Mysore, Karnataka, India

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Trivandrum, Kerala, India

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Indore, Madhya Pradesh, India

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Nagpur, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Coimbatore, Tamil Nadu, India

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Nagoya, Aichi-ken, Japan

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Okazaki, Aichi-ken, Japan

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Seto, Aichi-ken, Japan

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Toyota, Aichi-ken, Japan

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Toyota-shi, Aichi-ken, Japan

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Akita, Akita, Japan

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Fukuoka, Fukuoka, Japan

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Yanagawa, Fukuoka, Japan

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Gifu, Gifu, Japan

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Takayama-shi, Gifu, Japan

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Maebashi, Gunma, Japan

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Ōta, Gunma, Japan

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Hiroshima, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Obihiro, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai, Hokkaido, Japan

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Himeji, Hyōgo, Japan

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Itami, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Naka-gun, Ibaragi, Japan

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Hitachi, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Sakaidechō, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Fujisawa, Kanagawa, Japan

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Kawasaki-shi, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Zama-shi, Kanagawa, Japan

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Kochi, Kochi, Japan

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Kyoto, Kyoto, Japan

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Matsusaka-shi, Mie-ken, Japan

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Murata, Miyagi, Japan

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Sendai, Miyagi, Japan

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Chino-shi, Nagano, Japan

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Matsumoto, Nagano, Japan

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Isahaya-shi, Nagasaki, Japan

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Nagaoka, Niigata, Japan

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Saiki-shi, Oita Prefecture, Japan

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Yufu-shi, Oita Prefecture, Japan

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Kurashiki-shi, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Urasoe-shi, Okinawa, Japan

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Izumi-shi, Osaka, Japan

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Kishiwada, Osaka, Japan

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Moriguchi, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai-shi, Osaka, Japan

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Saga, Saga-ken, Japan

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Kitakatsushika-gun, Saitama, Japan

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Koshigaya-shi, Saitama, Japan

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Matsue, Shimane, Japan

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Chūō, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Meguro City, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Setagaya City, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Suginami-ku, Tokyo, Japan

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Sumida-ku, Tokyo, Japan

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Wakayama, Wakayama, Japan

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San Fernando City, Pampanga, Philippines

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Davao City, Philippines, Philippines

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Iloilo City, Philippines

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Lipa City, Batangas, Philippines

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Olongapo City, Philippines

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Quezon City, Philippines

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Bialystok, Poland

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Bydgoszcz, Poland

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Chodzież, Poland

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Jarosław, Poland

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Karpacz, Poland

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Krakow, Poland

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Lodz, Poland

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Loma, Poland

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Lublin, Poland

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Ostrów Wielkopolski, Poland

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Piła, Poland

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Poznan, Poland

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Ruda Śląska, Poland

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Słupca, Poland

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Tczew, Poland

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Torun, Poland

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Turek, Poland

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Włoszczowa, Poland

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Zabrze, Poland

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Zawadzkie, Poland

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Żnin, Poland

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Barnaul, Russia, Russia

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Kazan', Russia, Russia

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Moscow, Russia, Russia

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Saint Petersburg, Russia, Russia

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Yekaterinburg, Russia, Russia

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Novosibirsk, Russia

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Vladikavkaz, Russia

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Ansan, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Chiayi City, Taiwan

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Kaohsiung City, Taiwan

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Keelung, Taiwan

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Taipei, Taiwan

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Dnipropetrovsk, Ukraine

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Donetsk, Ukraine

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Kyiv, Ukraine

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Poltava, Ukraine

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Uzhhorod, Ukraine

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Vinytsa, Ukraine

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Zaporozye, Ukraine

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Ho Chi Minh City, Vietnam, Vietnam

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Hanoi, Vietnam

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Lars-Göran Carlsson, MD

  AstraZeneca R&D, Lund, Sweden

  STUDY CHAIR

• Yoshinosuke Fukuchi, M.D., PhD

  Department of Respiratory medicine, Juntendo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 17, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 25, 2012
• Results First Posted: October 25, 2012

Record last verified: 2012-09

Locations

PL (21); KR (3); IN (7); RU (7); TW (4); UA (7); VN (2); PH (6); JP (62)