Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— SECURE2  

Official title:

Efficacy and Tolerability Study of Symbicort Turbuhaler(160/4.5µg/Inhalation,2inhalations Twice Daily) Added to Atrovent (20µg/Inhalation, 2 Inhalations 4 Times Daily)+Theophylline SR(0.1g/Tablet,1 Tablet p.o. Twice Daily) Compared With Atrovent+Theophylline SR in Severe COPD Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415518
• Other study ID #: D589BL00022
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2011
• Est. completion date: December 1, 2012

Study information

• Verified date: June 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.

Description:

Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, 1 tablet p.o. twice daily) compared with Atrovent + theophylline SR in severe COPD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: December 1, 2012
• Est. primary completion date: December 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• 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

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Drug: Budesonide/formoterol (Symbicort Turbuhaler
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
• Drug: ipratropium (AtroventTM)
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
• theophylline SR
theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Changsha	Hunan
China	Research Site	Chengdu
China	Research Site	Chongqin
China	Research Site	Da Lian
China	Research Site	Foshan	Guangdong
China	Research Site	Guangzhou	Guangdong
China	Research Site	Ha'er BING
China	Research Site	Haikou	Hainan
China	Research Site	Huhehaote
China	Research Site	Nanjing	Jiangsu
China	Research Site	Qingdao	Shandong
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Shijiazhuang	Hebei
China	Research Site	Tangshan	Hebei
China	Research Site	Tianjin	Tianjin
China	Research Site	Wuhan	Hubei
China	Research Site	Zhengzhou	Henan
China	Research Site	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

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
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
Secondary	Post-dose FEV1 at 60 Minutes	Ratio of post-dose FEV1 at 60 minutes to baseline value	Baseline (meaured 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)
Secondary	Pre-dose FVC	Ratio of pre-dose FVC (Forced Vital Capacity) to baseline	Baseline (meaured 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)
Secondary	Post-dose FVC at 5 Minutes	Ratio of post-dose FVC at 5 minutes to baseline	Baseline (meaured 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)
Secondary	Post-dose FVC at 60 Minutes	Ratio of post-dose FVC at 60 minutes to baseline	Baseline (meaured 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)
Secondary	Pre-dose IC	Ratio of pre-dose IC (Inspiratory Capacity) to baseline	Baseline (meaured 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)
Secondary	Post-dose IC at 60 Minutes	Ratio of post-dose IC at 60 minutes to baseline	Baseline (meaured 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)
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
Secondary	Pre-dose PEF in First Week of Treatment	Change in pre-dose morning PEF 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 measurments measured before inhalation of study drug in the first week of treatment
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 (12 weeks)
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
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 measurments measured at 5 minutes after inhalation of study drug in the first week of treatment
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 (12 weeks)
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 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
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 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
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 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 (12 weeks)
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 (12 weeks)
Secondary	COPD Symptoms - Cough	Change in cough symptom score (from 0 (none) to 4 (almost constant)) 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 (12 weeks)
Secondary	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 (12 weeks)
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 (12 weeks)
Secondary	Use of Reliever Medication During Night in the Last Week on Treatment	Change in the number of inhalations of reliever medication during day from run-in 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 night in the last week on treatment
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 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
Secondary	Use of Reliever Medication During Night in the Whole Treatment Period	Change in the number of inhalations of reliever medication during day from run-in 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 night in the whole treatment period (12 weeks)

External Links

•   Clinical Study Protocol
•   CSR Synopsis