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

AstraZeneca581 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

581

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Drug: Budesonide/formoterol (Symbicort TurbuhalerDRUG

budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)

Drug: ipratropium (AtroventTM)DRUG

ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)

theophylline SRDRUG

theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (21)

Research Site

Beijing, Beijing Municipality, China

Research Site

Foshan, Guangdong, China

Outcomes

Primary Outcomes

Pre-dose FEV1

Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value

Time frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug

Secondary Outcomes

Post-dose FEV1 at 5 Minutes

Ratio of post-dose FEV1 at 5 minutes to baseline value

Time frame: Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug

Post-dose FEV1 at 60 Minutes

Ratio of post-dose FEV1 at 60 minutes to baseline value

Time frame: 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)

Pre-dose FVC

Ratio of pre-dose FVC (Forced Vital Capacity) to baseline

Time frame: 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)

Post-dose FVC at 5 Minutes

Ratio of post-dose FVC at 5 minutes to baseline

Time frame: 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)

Post-dose FVC at 60 Minutes

Ratio of post-dose FVC at 60 minutes to baseline

Time frame: 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)

Data from ClinicalTrials.gov

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Guangzhou, Guangdong, China

Research Site

Zhongshan, Guangdong, China

Research Site

Haikou, Hainan, China

Research Site

Shijiazhuang, Hebei, China

Research Site

Tangshan, Hebei, China

Research Site

Zhengzhou, Henan, China

Research Site

Wuhan, Hubei, China

Research Site

Changsha, Hunan, China

...and 11 more locations

Ratio of pre-dose IC (Inspiratory Capacity) to baseline

Time frame: 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)

Post-dose IC at 60 Minutes

Ratio of post-dose IC at 60 minutes to baseline

Time frame: 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)

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

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

Pre-dose PEF in First Week of Treatment

Change in pre-dose morning PEF from run-in period to first week of treatment

Time frame: 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

Pre-dose PEF in Whole Treatment Period

Change in pre-dose morning PEF from run-in period to 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 (12 weeks)

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

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

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

Time frame: 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

Post-dose PEF in Whole Treatment Period

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

Change in the number of inhalations of reliever medication during day from run-in to 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

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

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

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

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 (12 weeks)

Change in COPD Symptoms - Breathing

Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period

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 (12 weeks)

COPD Symptoms - Cough

Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period

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 (12 weeks)

COPD Symptoms Sputum

Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period

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 (12 weeks)

COPD Exacerbations

Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms

Time frame: Whole treatment period (12 weeks)

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

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 last week on treatment

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

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

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

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 whole treatment period (12 weeks)