Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients - Full Text View

Purpose

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

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Drug: Budesonide/formoterol (Symbicort Turbuhaler Drug: Drug: ipratropium (AtroventTM ) Drug: theophylline SR	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Theophylline Aminophylline dihydrate Ipratropium bromide Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change from Baseline in pre-dose Forced Expiratory Volume (FEV) at 1 week [ Time Frame: Baseline,1 week ] [ Designated as safety issue: No ]
Change from Baseline in pre-dose Forced Expiratory Volume (FEV) in 1 second at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in pre-dose Forced Expiratory Volume (FEV) in 1 second at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in pre-dose Forced Vital Capacity (FVC) at 1 week [ Time Frame: Baseline , 1 week ] [ Designated as safety issue: No ]
Change from Baseline in pre-dose Forced Vital Capacity (FVC) at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in pre-dose Forced Vital Capacity (FVC) at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FVC at 5 minutes at 1 week [ Time Frame: Baseline, 1 week ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FVC at 5 minutes at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FVC at 5 minutes at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Inspiratory Capacity (IC) at 1 week [ Time Frame: Baseline, 1 week ] [ Designated as safety issue: No ]
Change from Baseline in Inspiratory Capacity (IC) at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Inspiratory Capacity (IC) at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
Change from Baseline in post-dose Forced Expiratory Volume in 1 second (FEV1) at 5 minutes at 1 week [ Time Frame: Baseline, 1 week ] [ Designated as safety issue: No ]
Change from Baseline in post-dose Forced Expiratory Volume in 1 second (FEV1) at 5 minutes at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose Forced Expiratory Volume in 1 second (FEV1) at 5 minutes at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FEV1 at 60 minutes at 1 week [ Time Frame: Baseline, 1 week ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FEV1 at 60 minutes at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FEV1 at 60 minutes at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FVC at 60 minutes at 1 week [ Time Frame: baseline, 1 week ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FVC at 60 minutes at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose FVC at 60 minutes at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose IC at 60 minutes at 1 week [ Time Frame: Baseline, 1 week ] [ Designated as safety issue: No ]
Change from Baseline in post-dose IC at 60 minutes at 6 weeks [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
Change from Baseline in post-dose IC at 60 minutes at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
To assess morning Peak Expiratory Flow (PEF) measured at home, pre- and post-intake of study drug at 5 minute [ Time Frame: Baseline (Visit 3) until the end of study (Visit 8) ] [ Designated as safety issue: No ]
To evaluate safety by assessing the nature, incidence and severity of Adverse Events (AEs) [ Time Frame: Visit 1 (Enrollment) until Visit 8 (the end of study) ] [ Designated as safety issue: Yes ]

Enrollment:	581
Study Start Date:	September 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415518

Locations

China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Foshan, Guangdong, China
Research Site
Guangzhou, Guangdong, China
Research Site
Zhongshan, Guangdong, China
China, Hainan
Research Site
Haikou, Hainan, China
China, Hebei
Research Site
Shijiazhuang, Hebei, China
Research Site
Tangshan, Hebei, China
China, Henan
Research Site
Zhengzhou, Henan, China
China, Hubei
Research Site
Hankou,wuhan, Hubei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shandong
Research Site
Qingdao, Shandong, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
China
Research Site
Chengdu, China
Research Site
Chongqin, China
Research Site
Da Lian, China
Research Site
Ha'er Bing, China
Research Site
Huhehaote, China

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:

Samuel Chen

AstraZeneca Singapore Pte Ltd

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01415518 History of Changes
Other Study ID Numbers:	D589BL00022
Study First Received:	August 8, 2011
Last Updated:	February 21, 2013
Health Authority:	China: Ethics Committee

Keywords provided by AstraZeneca:

Severe chronic obstructive pulmonary disease (COPD) patients

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Theophylline
Ipratropium
Budesonide
Formoterol
Symbicort
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents
Cholinergic Antagonists
Cholinergic Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 23, 2013

Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients (SECURE 2)