Clinical trial NCT01001494: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
antimuscarinic
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 828
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 main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Eligibility criteria: Inclusion Criteria:

* Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
* Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

* Patients with no history or current diagnosis of asthma.
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Primary outcomes:
measure: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
timeFrame: Baseline and Week 24
measure: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
timeFrame: Baseline and Week 24
measure: Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment
timeFrame: Week 24
measure: Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment
timeFrame: Week 24
Other outcomes:
Locations:
city: Benesov
country: Czech Republic
facility: Almirall Investigational Sites#4
city: Jaromer
country: Czech Republic
facility: Almirall Investigational Sites#9
city: Liberec
country: Czech Republic
facility: Almirall Investigational Sites#3
city: Lovosice
country: Czech Republic
facility: Almirall Investigational Sites#2
city: Neratovice
country: Czech Republic
facility: Almirall Investigational Sites#1
city: Praha
country: Czech Republic
facility: Almirall Investigational Sites#11
city: Praha
country: Czech Republic
facility: Almirall Investigational Sites#6
city: Praha
country: Czech Republic
facility: Almirall Investigational Sites#12
city: Praha
country: Czech Republic
facility: Almirall Investigational Sites#7
city: Strakonice
country: Czech Republic
facility: Almirall Investigational Sites#10
city: Clermont-Ferrand Cedex
country: France
facility: Almirall Investigational Sites#3
city: Marseille Cedex 20
country: France
facility: Almirall Investigational Sites#1
city: Marseille
country: France
facility: Almirall Investigational Sites#2
city: Montpellier
country: France
facility: Almirall Investigational Sites#6
city: Toulouse Cedex
country: France
facility: Almirall Investigational Sites#4
city: Berlin
country: Germany
facility: Almirall Investigational Sites#8
city: Berlin
country: Germany
facility: Almirall Investigational Sites#9
city: Berlin
country: Germany
facility: Almirall Investigational Sites#6
city: Berlin
country: Germany
facility: Almirall Investigational Sites#14
city: Berlin
country: Germany
facility: Almirall Investigational Site#7
city: Bonn
country: Germany
facility: Almirall Investigational Sites#12
city: Dortmund
country: Germany
facility: Almirall Investigational Sites#3
city: Frankfurt
country: Germany
facility: Almirall Investigational Sites#13
city: Gelsenkirchen
country: Germany
facility: Almirall Investigational Sites#15
city: Grosshansdorf
country: Germany
facility: Almirall Investigational Sites#1
city: Hamburg
country: Germany
facility: Almirall Investigational Sites#5
city: Hamburg
country: Germany
facility: Almirall Investigational Sites#4
city: Hannover
country: Germany
facility: Almirall Investigational Site#16
city: Jena
country: Germany
facility: Almirall Investigational Sites#18
city: Koln
country: Germany
facility: Almirall Investigational Sites#10
city: Mainz
country: Germany
facility: Almirall Investigational Sites#11
city: Rüdersdorf
country: Germany
facility: Almirall Investigational Site#2
city: Budapest
country: Hungary
facility: Almirall Investigational Sites#13
city: Budapest
country: Hungary
facility: Almirall Investigational Sites#4
city: Budapest
country: Hungary
facility: Almirall Investigational Sites#1
city: Budapest
country: Hungary
facility: Almirall Investigational Sites#2
city: Debrecen
country: Hungary
facility: Almirall Investigational Sites#6
city: Debrecen
country: Hungary
facility: Almirall Investigational Sites#5
city: Deszk
country: Hungary
facility: Almirall Investigational Sites#7
city: Dunaüjváros
country: Hungary
facility: Almirall Investigational Sites#10
city: Mátraháza
country: Hungary
facility: Almirall Investigational Sites#9
city: Pécs
country: Hungary
facility: Almirall Investigational Sites#12
city: Ráckeve
country: Hungary
facility: Almirall Investigational Sites#11
city: Százhalombatta
country: Hungary
facility: Almirall Investigational Sites#3
city: Zalaegerszeg
country: Hungary
facility: Almirall Investigational Sites#8
city: Cagliari
country: Italy
facility: Almirall Investigational Sites#3
city: Genova
country: Italy
facility: Almirall Investigational Sites#1
city: Pisa
country: Italy
facility: Almirall Investigational Sites#10
city: Cusco
country: Peru
facility: Almirall Investigational Sites#8
city: Białystok
country: Poland
facility: Almirall Investigational Sites#12
city: Białystok
country: Poland
facility: Almirall Investigational Sites#9
city: Elblag
country: Poland
facility: Almirall Investigational Sites#19
city: Gdansk
country: Poland
facility: Almirall Investigational Sites#18
city: Ilawa
country: Poland
facility: Almirall Investigational Sites#20
city: Lodz
country: Poland
facility: Almirall Investigational Sites#7
city: Lodz
country: Poland
facility: Almirall Investigational Sites#1
city: Lublin
country: Poland
facility: Almirall Investigational Sites#8
city: Olsztyn
country: Poland
facility: Almirall Investigational Sites#24
city: Olsztyn
country: Poland
facility: Almirall Investigational Sites#5
city: Poznan
country: Poland
facility: Almirall Investigational Sites#21
city: Poznan
country: Poland
facility: Almirall Investigational Sites#16
city: Proszowice
country: Poland
facility: Almirall Investigational Site#11
city: Ruda Slaska
country: Poland
facility: Almirall Investigational Sites#2
city: Rudka
country: Poland
facility: Almirall Investigational Sites#13
city: Sopot
country: Poland
facility: Almirall Investigational Sites#4
city: Szczecin
country: Poland
facility: Almirall Investigational Sites#14
city: Tarnow
country: Poland
facility: Almirall Investigational Sites#6
city: Tarnów
country: Poland
facility: Almirall Investigational Sites#15
city: Warszawa
country: Poland
facility: Almirall Investigational Sites#25
city: Wilkowice-Bystra
country: Poland
facility: Almirall Investigational Sites#23
city: Wrocław
country: Poland
facility: Almirall Investigational Site#10
city: Ekaterinburg
country: Russian Federation
facility: Almirall Investigational Sites#7
city: Kazan
country: Russian Federation
facility: Almirall Investigational Sites#5
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#2
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#14
city: Moscow
country: Russian Federation
facility: Almirall Investigational Sites#6
city: Novosibirsk
country: Russian Federation
facility: Almirall Investigational Sites#13
city: Saint-Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#10
city: Saint-Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#3
city: Saint-Petersburg
country: Russian Federation
facility: Almirall Investigational Sites#4
city: Tomsk
country: Russian Federation
facility: Almirall Investigational Sites#8
city: Tomsk
country: Russian Federation
facility: Almirall Investigational Sites#12
city: Bloemfontein
country: South Africa
facility: Almirall Investigational Sites#8
city: Bloemfontein
country: South Africa
facility: Almirall Investigational Sites#11
city: Bloemfontein
country: South Africa
facility: Almirall Investigational Sites#3
city: Cape Town
country: South Africa
facility: Almirall Investigational Sites#10
city: Cape Town
country: South Africa
facility: Almirall Investigational Sites#1
city: Cape Town
country: South Africa
facility: Almirall Investigational Sites#12
city: Cape Town
country: South Africa
facility: Almirall Investigational Sites#15
city: Durban
country: South Africa
facility: Almirall Investigational Sites#2
city: George
country: South Africa
facility: Almirall Investigational Sites#9
city: Port Elizabeth
country: South Africa
facility: Almirall Investigational Sites#4
city: Pretoria
country: South Africa
facility: Almirall Investigational Sites#5
city: Pretoria
country: South Africa
facility: Almirall Investigational Sites#14
city: Pretoria
country: South Africa
facility: Almirall Investigational Sites#6
city: Badalona
country: Spain
facility: Almirall Investigational Sites#6
city: Barcelona
country: Spain
facility: Almirall Investigational Sites#8
city: Barcelona
country: Spain
facility: Almirall Investigational Sites#7
city: Madrid
country: Spain
facility: Almirall Investigational Sites#3
city: Valencia
country: Spain
facility: Almirall Investigational Sites#5
city: Donetsk
country: Ukraine
facility: Almirall Investigational Sites#4
city: Kharkiv
country: Ukraine
facility: Almirall Investigational Sites#3
city: Kyiv
country: Ukraine
facility: Almirall Investigational Sites#1
city: Kyiv
country: Ukraine
facility: Almirall Investigational Sites#2
city: Kyiv
country: Ukraine
facility: Almirall Investigational Sites#7
city: Zaporizhzhya
country: Ukraine
facility: Almirall Investigational Sites#5
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
citation: Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
citation: Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.
citation: Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.