Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Drug: Budesonide/formoterol (Symbicort Turbuhaler (Drug); Drug: ipratropium (AtroventTM) (Drug); theophylline SR (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Samuel Chen, Study Chair, Affiliation: AstraZeneca Singapore Pte Ltd
Summary
Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD)
patients.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pre-dose FEV1
Secondary outcome: Post-dose FEV1 at 5 MinutesPost-dose FEV1 at 60 Minutes Pre-dose FVC Post-dose FVC at 5 Minutes Post-dose FVC at 60 Minutes Pre-dose IC Post-dose IC at 60 Minutes Pre-dose PEF in Last Week of Treatment Pre-dose PEF in First Week of Treatment Pre-dose PEF in Whole Treatment Period Post-dose PEF in Last Week of Treatment Post-dose PEF in First Week of Treatment Post-dose PEF in Whole Treatment Period Use of Reliever Medication During Day in the Last Week on Treatment Use of Reliever Medication During Day in the First Week on Treatment Use of Reliever Medication During Day in the Whole Treatment Period Change in COPD Symptoms - Breathing COPD Symptoms - Cough COPD Symptoms Sputum COPD Exacerbations Use of Reliever Medication During Night in the Last Week on Treatment Use of Reliever Medication During Night in the First Week on Treatment Use of Reliever Medication During Night in the Whole Treatment Period
Detailed 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.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
- 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 and Contacts
Research Site, Chengdu, China
Research Site, Chongqin, China
Research Site, Da Lian, China
Research Site, Ha'er Bing, China
Research Site, Huhehaote, China
Research Site, Beijing, Beijing, China
Research Site, Foshan, Guangdong, China
Research Site, 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
Research Site, Nanjing, Jiangsu, China
Research Site, Changchun, Jilin, China
Research Site, Shenyang, Liaoning, China
Research Site, Qingdao, Shandong, China
Research Site, Shanghai, Shanghai, China
Research Site, Tianjin, Tianjin, China
Additional Information
Starting date: September 2011
Last updated: August 11, 2014
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