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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(160/4.5g/Inhalation,2inhalations Twice Daily) Added to Atrovent (20g/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 Minutes

Post-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. 5g/inhalation,2inhalations twice daily) added to Atrovent (20g/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

Page last updated: August 23, 2015

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