Clinical trial NCT00206154: A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients
Official title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of COPD with symptoms for more than 2 years
* Smoking history of 10 or more pack years
* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

* A history of asthma
* Patients taking oral steroids.
* Any significant disease or disorder that may jeopardize the safety of the patient

Primary outcomes:
measure: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
Secondary outcomes:
measure: Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
measure: Health care utilization
measure: Pharmacokinetics (subgroup)
measure: Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
measure: - all variables assessed over the 6 months treatment period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Jasper
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
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state: Alabama
city: Glendale
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state: Arizona
city: Mesa
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city: Phoenix
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city: San Diego
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city: Stockton
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city: Torrance
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city: Denver
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city: Waterbury
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city: Sunset
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city: Bangor
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city: Baltimore
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city: Taunton
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city: Minneapolis
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city: Plymouth
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city: St Paul
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city: St. Charles
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city: Butte
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city: Missoula
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city: Buffalo
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city: Salem
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state: Wisconsin
city: Praha 8
country: Czech Republic
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state: CZ
city: Ústí nad Labem
country: Czech Republic
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state: CZ
city: Beroun
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city: Cvikov
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city: Jarom¿¿
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city: Karlovy Vary
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country: Czech Republic
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city: Praha 1
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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city: Tilburg
country: Netherlands
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city: Utrecht
country: Netherlands
facility: Research Site
city: Bia¿ystok
country: Poland
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city: Bydgoszcz
country: Poland
facility: Research Site
city: Bystra ¿l¿ska
country: Poland
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city: Chrzanów
country: Poland
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city: Ch¿ciny
country: Poland
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city: Cz¿stochowa
country: Poland
facility: Research Site
city: Gidle
country: Poland
facility: Research Site
city: Gorzów Wlkp
country: Poland
facility: Research Site
city: I¿awa
country: Poland
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city: Karpacz
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
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city: Ostrów Wielkopolski
country: Poland
facility: Research Site
city: Otowck
country: Poland
facility: Research Site
city: Pozna¿
country: Poland
facility: Research Site
city: Proszowice
country: Poland
facility: Research Site
city: Radom
country: Poland
facility: Research Site
city: Siedlce
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Tarnów
country: Poland
facility: Research Site
city: Turek
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wo¿omin
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zawadzkie
country: Poland
facility: Research Site
city: ¿om¿a
country: Poland
facility: Research Site
city: ¿ód¿
country: Poland
facility: Research Site
city: Parow
country: South Africa
facility: Research Site
state: Cape Province
city: Lenasia
country: South Africa
facility: Research Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Witbank
country: South Africa
facility: Research Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Port Elizabeth
country: South Africa
facility: Research Site
city: Umkomaas
country: South Africa
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
citation: Make BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Ostlund O, Anzueto A. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015 Jan 27;10:201-9. doi: 10.2147/COPD.S69589. eCollection 2015.
citation: Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, Martin UJ. ADRB2 polymorphisms and budesonide/formoterol responses in COPD. Chest. 2012 Aug;142(2):320-328. doi: 10.1378/chest.11-1655.