Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— SECURE2Official 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.
Verified date | June 2019 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
China,
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) |
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