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)

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ClinicalTrials.gov Identifier: NCT01397890

Recruitment Status : Completed

First Posted : July 20, 2011

Results First Posted : August 27, 2014

Last Update Posted : March 27, 2015

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief Summary:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	793 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	July 2011
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Drug Information available for: Formoterol fumarate Budesonide Formoterol Tiotropium bromide Arformoterol Tartrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Pre-dose FEV1 [ Time Frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug ]
Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value

Secondary Outcome Measures :

Post-dose FEV1 at 5 Minutes [ Time Frame: Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug ]
Ratio of post-dose FEV1 at 5 minutes to baseline value
Post-dose FEV1 at 60 Minutes [ Time Frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) ]
Ratio of post-dose FEV1 at 60 minutes to baseline value
Pre-dose FVC [ Time Frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) ]
Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value
Post-dose FVC at 5 Minutes [ Time Frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12) ]
Ratio of post-dose FVC at 5 minutes to baseline value
Post-dose FVC at 60 Minutes [ Time Frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) ]
Ratio of post-dose FVC at 60 minutes to baseline value
Pre-dose IC [ Time Frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug ]
Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value
Post-dose IC at 60 Minutes [ Time Frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) ]
Ratio of post-dose IC at 60 minutes to baseline value
Pre-dose PEF in Last Week of Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks ]
Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment
Pre-dose PEF in First Week of Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment ]
Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment
Pre-dose PEF in Whole Treatment Period [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks ]
Change in pre-dose morning PEF from run-in period to whole treatment period
Post-dose PEF in Last Week of Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks ]
Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment
Post-dose PEF in First Week of Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment ]
Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment
Post-dose PEF in Whole Treatment Period [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks ]
Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period
Use of Reliever Medication During Day in the Last Week on Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks ]
Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment
Use of Reliever Medication During Day in the First Week on Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment ]
Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment
Use of Reliever Medication During Day in the Whole Treatment Period [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks ]
Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period
Use of Reliever Medication During Night in the Last Week on Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks ]
Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment
Use of Reliever Medication During Night in the First Week on Treatment [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment ]
Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment
Use of Reliever Medication During Night in the Whole Treatment Period [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks ]
Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period
Change in COPD Symptoms - Breathing [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks ]
Change in breathing symptom score (from 0:none to 4:severe) from run-in period
Change in COPD Symptoms - Cough [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks ]
Change in Cough symptom score (from 0:none to 4:severe) from run-in period
Change in COPD Symptoms - Sputum [ Time Frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks ]
Change in Sputum symptom score (from 0:none to 4:severe) from run-in period
COPD Exacerbations [ Time Frame: Whole treatment period of 12 weeks ]
Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397890

Locations

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China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Liaoning
Research Site
Shen Yang, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Taiyuan, Shanxi, China
China
Research Site
Guang Zhou, China
Hong Kong
Research Site
Kowloon, HK, Hong Kong
Research Site
Hong Kong, Hong Kong
Indonesia
Research Site
Jakarta, Indonesia
Research Site
Solo, Indonesia
Research Site
Surabaya, Indonesia
Korea, Republic of
Research Site
Wonju-si, Gangwon-do, Korea, Republic of
Research Site
Suwon-si, Gyeonggi-do, Korea, Republic of
Research Site
Jinju-si, Gyeongsangnam-do, 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
Seoul, Korea, Republic of
Thailand
Research Site
Muang, NAN, Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Chonburi, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Nonthaburi, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Songkhla, Thailand
Research Site
Udon Thani, Thailand

Sponsors and Collaborators

AstraZeneca

Investigators

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Study Chair:	Samuel Chen, M.D.	AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee SD, Xie CM, Yunus F, Itoh Y, Ling X, Yu WC, Kiatboonsri S. Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD: A randomized, multicentre study in East Asia. Respirology. 2016 Jan;21(1):119-27. doi: 10.1111/resp.12646. Epub 2015 Sep 23.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01397890
Other Study ID Numbers:	D589BL00023
First Posted:	July 20, 2011 Key Record Dates
Results First Posted:	August 27, 2014
Last Update Posted:	March 27, 2015
Last Verified:	March 2015

Keywords provided by AstraZeneca:


Severe chronic obstructive pulmonary disease (COPD) patients

Additional relevant MeSH terms:

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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Budesonide Formoterol Fumarate Tiotropium Bromide Budesonide, Formoterol Fumarate Drug Combination Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents	Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Parasympatholytics Cholinergic Antagonists Cholinergic Agents

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