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)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— SECURE 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397890
• Other study ID #: D589BL00023
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2011
• Last updated: March 25, 2015
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee, Ministry of Health, National Natural Science Foundation, State Food and Drug AdministrationHong Kong: Department of Health, Joint CUHK-NTEC Clinical Research Ethics CommitteeHong Kong: HKU/HA HKW IRB, NTW Cluster Clinical & Research Ethics Committee, Clinical Research Ethics Committee, Kowloon West ClusterIndonesia: Departement Kesehatan (Department of Health, National Agency of Drug and Food Control, Ethics CommitteeKorea: Food and Drug AdministrationThailand: Ethical Committee, Ministry of Public Health, Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Budesonide/formoterol (Symbicort® Turbuhaler®)
Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5µg/inhalation, 2 inhalations twice daily
• Tiotropium (SpirivaTM)
Tiotropium (SpirivaTM) 18 µg/inhalation, 1 inhalation once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  Hong Kong,  Indonesia,  Korea, Republic of,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dose FEV1	Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value	Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug	No
Secondary	Post-dose FEV1 at 5 Minutes	Ratio of post-dose FEV1 at 5 minutes to baseline value	Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug	No
Secondary	Post-dose FEV1 at 60 Minutes	Ratio of post-dose FEV1 at 60 minutes to baseline value	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)	No
Secondary	Pre-dose FVC	Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value	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)	No
Secondary	Post-dose FVC at 5 Minutes	Ratio of post-dose FVC at 5 minutes to baseline value	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)	No
Secondary	Post-dose FVC at 60 Minutes	Ratio of post-dose FVC at 60 minutes to baseline value	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)	No
Secondary	Pre-dose IC	Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value	Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug	No
Secondary	Post-dose IC at 60 Minutes	Ratio of post-dose IC at 60 minutes to baseline value	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)	No
Secondary	Pre-dose PEF in Last Week of Treatment	Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment	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	No
Secondary	Pre-dose PEF in First Week of Treatment	Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment	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	No
Secondary	Pre-dose PEF in Whole Treatment Period	Change in pre-dose morning PEF from run-in period to whole treatment period	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	No
Secondary	Post-dose PEF in Last Week of Treatment	Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment	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	No
Secondary	Post-dose PEF in First Week of Treatment	Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment	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	No
Secondary	Post-dose PEF in Whole Treatment Period	Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period	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	No
Secondary	Use of Reliever Medication During Day in the Last Week on Treatment	Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment	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	No
Secondary	Use of Reliever Medication 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	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	No
Secondary	Use of Reliever Medication During Day in the Whole Treatment Period	Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period	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	No
Secondary	Use of Reliever Medication During Night in the Last Week on Treatment	Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment	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	No
Secondary	Use of Reliever Medication 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	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	No
Secondary	Use of Reliever Medication During Night in the Whole Treatment Period	Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period	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	No
Secondary	Change in COPD Symptoms - Breathing	Change in breathing symptom score (from 0:none to 4:severe) from run-in period	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	No
Secondary	Change in COPD Symptoms - Cough	Change in Cough symptom score (from 0:none to 4:severe) from run-in period	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	No
Secondary	Change in COPD Symptoms - Sputum	Change in Sputum symptom score (from 0:none to 4:severe) from run-in period	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	No
Secondary	COPD Exacerbations	Severe exacerbations requiring systemic steroids (oral =3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms	Whole treatment period of 12 weeks	No