Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) (SECURE 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01397890
First received: June 27, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Budesonide/formoterol (Symbicort® Turbuhaler®)
Drug: Tiotropium (SpirivaTM)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Parallel-group, Open-label, Multicentre, 3-month Phase IV, Efficacy and Tolerability Study of Budesonide/Formoterol (Symbicort® Turbuhaler® 160/4.5μg/Inhalation, 2 Inhalations Twice Daily) Added to Tiotropium (SpirivaTM 18 μg/Inhalation, 1 Inhalation Once Daily) Compared With Tiotropium (SpirivaTM18 μg/Inhalation, 1 Inhalation Once Daily) Alone in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Evaluate the efficacy on lung function: Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Change FEV1 from baseline to an average of 12- week treatment ] [ Designated as safety issue: No ]
    (FEV1) of tiotropium bromide (Spiriva®) 18 μg one inhalation once a day + budesonide/formoterol (Symbicort®) Turbuhaler® 160/4.5 μg, two inhalations twice daily compared to tiotropium 18 μg one inhalation once daily alone


Secondary Outcome Measures:
  • To assess morning pre-dose Forced Vital Capacity (FVC), Inspiratory Capacity (IC) and post-dose Forced Expiratory Volume in 1 second (FEV1), FVC at 5 minutes and FEV1, FVC and IC at 60 minutes at clinic visit [ Time Frame: Change from baseline to an average of 12- week treatment ] [ Designated as safety issue: No ]
  • To assess morning Peak Expiratory Flow (PEF) measured at home, pre- and post-intake of study drug at 5 minutes [ Time Frame: Change PEF from baseline to an average of 12- week treatment ] [ Designated as safety issue: No ]
  • To evaluate safety by assessing the nature, incidence and severity of Adverse Events (AEs) [ Time Frame: Visit 1 (Enrolment) through Visit 8 (the end of study) ] [ Designated as safety issue: Yes ]

Enrollment: 793
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Add-on treatment
Drug: Budesonide/formoterol (Symbicort® Turbuhaler®)
Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily
Drug: Tiotropium (SpirivaTM)
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
2
Add-on treatment
Drug: Tiotropium (SpirivaTM)
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent
  • Men or women patients ≥40 years of age
  • Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
  • Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 70%, pre-bronchodilator
  • Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period

Exclusion Criteria:

  • A history of asthma and seasonal allergic rhinitis before 40 years of age
  • Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
  • Patients with relevant cardiovascular disorder judged by the investigator
  • Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
  • Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397890

Locations
China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Changsha, China
Research Site
Guang Zhou, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
Research Site
Shen Yang, China
Research Site
Taiyuan, China
Hong Kong
Research Site
Hong kong, Hong Kong
Research Site
Hongkong, Hong Kong
Research Site
Kowloon, Hong Kong
Indonesia
Research Site
Jakarta, Indonesia
Research Site
Solo, Indonesia
Research Site
Surabaya, Indonesia
Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Incheon, Korea, Republic of
Research Site
Jinju-si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon-si, Korea, Republic of
Research Site
Wonju-si, Korea, Republic of
Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Chonburi, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Muang,, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Songkhla, Thailand
Research Site
Udon Thani, Thailand
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Samuel Chen, M.D. AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01397890     History of Changes
Other Study ID Numbers: D589BL00023
Study First Received: June 27, 2011
Last Updated: June 16, 2014
Health Authority: China: Ethics Committee, Ministry of Health, National Natural Science Foundation, State Food and Drug Administration
Hong Kong: Department of Health, Joint CUHK-NTEC Clinical Research Ethics Committee
Hong Kong: HKU/HA HKW IRB, NTW Cluster Clinical & Research Ethics Committee, Clinical Research Ethics Committee, Kowloon West Cluster
Indonesia: Departement Kesehatan (Department of Health, National Agency of Drug and Food Control, Ethics Committee
Korea: Food and Drug Administration
Thailand: Ethical Committee, Ministry of Public Health, Food and Drug Administration

Keywords provided by AstraZeneca:
Severe chronic obstructive pulmonary disease (COPD) patients

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Tiotropium
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 28, 2014