Clinical trial NCT00363896: A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Official title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lung function
Exacerbations
Quality of Life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 843
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: To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Eligibility criteria: Inclusion Criteria:

* Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Primary outcomes:
measure: Trough FEV1 (L) at 28 Weeks on Treatment
timeFrame: Week 28
measure: Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment
timeFrame: Week 12
Secondary outcomes:
measure: Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
timeFrame: Week 52
measure: Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Escaldes
country: Andorra
facility: Almirall Investigational Sites#947
city: Graz
country: Austria
facility: Almirall Investigational Sites#645
city: Innsbruck
country: Austria
facility: Almirall Investigational Sites#646
city: Linz
country: Austria
facility: Almirall Investigational Sites#644
city: Wien
country: Austria
facility: Almirall Investigational Sites#647
city: Wien
country: Austria
facility: Almirall Investigational Sites#649
city: Aalst
country: Belgium
facility: Almirall Investigational Sites#110
city: Brussels
country: Belgium
facility: Almirall Investigational Sites#394
city: Edegem
country: Belgium
facility: Almirall Investigational Sites#651
city: Namur
country: Belgium
facility: Almirall Investigational Sites#393
city: Burgas
country: Bulgaria
facility: Almirall Investigational Sites#658
city: Pleven
country: Bulgaria
facility: Almirall Investigational Sites#653
city: Plovdiv
country: Bulgaria
facility: Almirall Investigational Sites#654
city: Russe
country: Bulgaria
facility: Almirall Investigational Sites#656
city: Sofia
country: Bulgaria
facility: Almirall Investigational Sites#652
city: Sofia
country: Bulgaria
facility: Almirall Investigational Sites#657
city: Sofia
country: Bulgaria
facility: Almirall Investigational Sites#972
city: Sofia
country: Bulgaria
facility: Almirall Investigational Sites#971
city: Varna
country: Bulgaria
facility: Almirall Investigational Sites#655
city: Veliko Tarnovo
country: Bulgaria
facility: Almirall Investigational Sites#953
city: Lovosice
country: Czech Republic
facility: Almirall Investigational Sites#664
city: Neratovice
country: Czech Republic
facility: Almirall Investigational Sites#660
city: Plzen
country: Czech Republic
facility: Almirall Investigational Sites#662
city: Prague
country: Czech Republic
facility: Almirall Investigational Sites#666
city: Praha
country: Czech Republic
facility: Almirall Investigational Sites#661
city: Tabor
country: Czech Republic
facility: Almirall Investigational Sites#665
city: Tremosna
country: Czech Republic
facility: Almirall Investigational Sites#659
city: Zatec
country: Czech Republic
facility: Almirall Investigational Sites#954
city: Aalborg
country: Denmark
facility: Almirall Investigational Sites#398
city: Odense C.
country: Denmark
facility: Almirall Investigational Sites#397
city: Århus C
country: Denmark
facility: Almirall Investigational Sites#390
city: Beuvry
country: France
facility: Almirall Investigational Sites#594
city: Brest Cedex
country: France
facility: Almirall Investigational Sites#593
city: Grasse
country: France
facility: Almirall Investigational Sites#750
city: Montpellier,cedex 5
country: France
facility: Almirall Investigational Sites#669
city: Paris
country: France
facility: Almirall Investigational Sites#672
city: Perpignan Cedex
country: France
facility: Almirall Investigational Sites#948
city: Rouen , Cedex
country: France
facility: Almirall Investigational Sites#549
city: Strasbourg Cedex
country: France
facility: Almirall Investigational Sites#671
city: Vieux Conde
country: France
facility: Almirall Investigational Sites#752
city: Bad Wörishofen
country: Germany
facility: Almirall Investigational Sites#678
city: Berlin-Spandau
country: Germany
facility: Almirall Investigational Sites#677
city: Berlin
country: Germany
facility: Almirall Investigational Sites#758
city: Berlin
country: Germany
facility: Almirall Investigational Sites#765
city: Berlin
country: Germany
facility: Almirall Investigational Sites#680
city: Bonn
country: Germany
facility: Almirall Investigational Sites#681
city: Grosshansdorf
country: Germany
facility: Almirall Investigational Sites#191
city: Hamburg
country: Germany
facility: Almirall Investigational Sites#766
city: Jena
country: Germany
facility: Almirall Investigational Sites#757
city: Mainz
country: Germany
facility: Almirall Investigational Sites#675
city: Budapest
country: Hungary
facility: Almirall Investigational Sites#684
city: Debrecen
country: Hungary
facility: Almirall Investigational Sites#687
city: Debrecen
country: Hungary
facility: Almirall Investigational Sites#683
city: Nyiregyhaza
country: Hungary
facility: Almirall Investigational Sites#688
city: Szekesfehervar
country: Hungary
facility: Almirall Investigational Sites#686
city: Szombathely
country: Hungary
facility: Almirall Investigational Sites#689
city: Tatabanya
country: Hungary
facility: Almirall Investigational Sites#682
city: Torokbalint
country: Hungary
facility: Almirall Investigational Sites#685
city: Genova
country: Italy
facility: Almirall Investigational Sites#459
city: Milano
country: Italy
facility: Almirall Investigational Sites#774
city: Modena
country: Italy
facility: Almirall Investigational Sites#286
city: Napoli
country: Italy
facility: Almirall Investigational Sites#694
city: Perugia
country: Italy
facility: Almirall Investigational Sites#635
city: Pordenone
country: Italy
facility: Almirall Investigational Sites#777
city: Breda
country: Netherlands
facility: Almirall Investigational Sites#346
city: Eindhoven
country: Netherlands
facility: Almirall Investigational Sites#551
city: Hengelo
country: Netherlands
facility: Almirall Investigational Sites#348
city: Hoofddorp
country: Netherlands
facility: Almirall Investigational Sites#695
city: Lodz
country: Poland
facility: Almirall Investigational Sites#700
city: Lodz
country: Poland
facility: Almirall Investigational Sites#698
city: Torun
country: Poland
facility: Almirall Investigational Sites#697
city: Warszawa
country: Poland
facility: Almirall Investigational Sites#699
city: Warszawa
country: Poland
facility: Almirall Investigational Sites#696
city: Warszawa
country: Poland
facility: Almirall Investigational Sites#702
city: Wroclaw
country: Poland
facility: Almirall Investigational Sites#706
city: Zabrze
country: Poland
facility: Almirall Investigational Sites#705
city: Zawadzkie
country: Poland
facility: Almirall Investigational Sites#701
city: Brasov
country: Romania
facility: Almirall Investigational Sites#962
city: Bucharest
country: Romania
facility: Almirall Investigational Sites#714
city: Bucuresti
country: Romania
facility: Almirall Investigational Sites#970
city: Cluj-Napoca
country: Romania
facility: Almirall Investigational Sites#713
city: Iasi
country: Romania
facility: Almirall Investigational Sites#712
city: Judetul Brasov
country: Romania
facility: Almirall Investigational Sites#961
city: Palazu Mare
country: Romania
facility: Almirall Investigational Sites#709
city: Targu Mures
country: Romania
facility: Almirall Investigational Sites#711
city: Timisoara
country: Romania
facility: Almirall Investigational Sites#715
city: Moscow region
country: Russian Federation
facility: Almirall Investigational Sites#717
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#462
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#977
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#721
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#540
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#967
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#716
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#722
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#719
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#582
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#785
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#976
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#588
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#720
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#965
city: saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#969
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#543
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#787
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#975
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#465
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#966
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#972
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#786
city: Saint Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#963
city: Sochi
country: Russian Federation
facility: Almirall Investigational Sites#718
city: Badalona
country: Spain
facility: Almirall Investigational Sites#16
city: Barcelona
country: Spain
facility: Almirall Investigational Sites#7
city: Barcelona
country: Spain
facility: Almirall Investigational Sites#317
city: Madrid
country: Spain
facility: Almirall Investigational Sites#61
city: Málaga
country: Spain
facility: Almirall Investigational Sites#938
city: Palma de Mallorca
country: Spain
facility: Almirall Investigational Sites#727
city: San Juan de Alicante
country: Spain
facility: Almirall Investigational Sites#723
city: Terrassa
country: Spain
facility: Almirall Investigational Sites#725
city: Bedford
country: United Kingdom
facility: Almirall Investigational Sites#738
city: Bristol
country: United Kingdom
facility: Almirall Investigational Sites#42
city: Cottingham
country: United Kingdom
facility: Almirall Investigational Sites#734
city: Doncaster
country: United Kingdom
facility: Almirall Investigational Sites#735
city: Exeter
country: United Kingdom
facility: Almirall Investigational Sites#788
city: Hereford
country: United Kingdom
facility: Almirall Investigational Sites#737
city: London
country: United Kingdom
facility: Almirall Investigational Sites#784
city: London
country: United Kingdom
facility: Almirall Investigational Sites#37
city: Newcastle upon Tyne
country: United Kingdom
facility: Almirall Investigational Sites#730
city: Peterborough
country: United Kingdom
facility: Almirall Investigational Sites#731
city: Solihull
country: United Kingdom
facility: Almirall Investigational Sites#728
city: Suffolk
country: United Kingdom
facility: Almirall Investigational Sites#732
city: Windsor
country: United Kingdom
facility: Almirall Investigational Sites#736
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.