Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001494
• Other study ID #: M/34273/34
• Secondary ID: ATTAIN
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2009
• Last updated: July 2, 2015
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: July 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium bromide 200 µg bid
Aclidinium bromide 200 µg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
• Aclidinium bromide 400 µg bid
Aclidinium bromide 400 µg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
• Placebo
Placebo twice-daily by inhalation for 24 weeks

Locations

Country	Name	City	State
Czech Republic	Almirall Investigational Sites#4	Benesov
Czech Republic	Almirall Investigational Sites#9	Jaromer
Czech Republic	Almirall Investigational Sites#3	Liberec
Czech Republic	Almirall Investigational Sites#2	Lovosice
Czech Republic	Almirall Investigational Sites#1	Neratovice
Czech Republic	Almirall Investigational Sites#11	Praha
Czech Republic	Almirall Investigational Sites#12	Praha
Czech Republic	Almirall Investigational Sites#6	Praha
Czech Republic	Almirall Investigational Sites#7	Praha
Czech Republic	Almirall Investigational Sites#10	Strakonice
France	Almirall Investigational Sites#3	Clermont-Ferrand Cedex
France	Almirall Investigational Sites#2	Marseille
France	Almirall Investigational Sites#1	Marseille Cedex 20
France	Almirall Investigational Sites#6	Montpellier
France	Almirall Investigational Sites#4	Toulouse Cedex
Germany	Almirall Investigational Site#7	Berlin
Germany	Almirall Investigational Sites#14	Berlin
Germany	Almirall Investigational Sites#6	Berlin
Germany	Almirall Investigational Sites#8	Berlin
Germany	Almirall Investigational Sites#9	Berlin
Germany	Almirall Investigational Sites#12	Bonn
Germany	Almirall Investigational Sites#3	Dortmund
Germany	Almirall Investigational Sites#13	Frankfurt
Germany	Almirall Investigational Sites#15	Gelsenkirchen
Germany	Almirall Investigational Sites#1	Grosshansdorf
Germany	Almirall Investigational Sites#4	Hamburg
Germany	Almirall Investigational Sites#5	Hamburg
Germany	Almirall Investigational Site#16	Hannover
Germany	Almirall Investigational Sites#18	Jena
Germany	Almirall Investigational Sites#10	Koln
Germany	Almirall Investigational Sites#11	Mainz
Germany	Almirall Investigational Site#2	Rüdersdorf
Hungary	Almirall Investigational Sites#1	Budapest
Hungary	Almirall Investigational Sites#13	Budapest
Hungary	Almirall Investigational Sites#2	Budapest
Hungary	Almirall Investigational Sites#4	Budapest
Hungary	Almirall Investigational Sites#5	Debrecen
Hungary	Almirall Investigational Sites#6	Debrecen
Hungary	Almirall Investigational Sites#7	Deszk
Hungary	Almirall Investigational Sites#10	Dunaüjváros
Hungary	Almirall Investigational Sites#9	Mátraháza
Hungary	Almirall Investigational Sites#12	Pécs
Hungary	Almirall Investigational Sites#11	Ráckeve
Hungary	Almirall Investigational Sites#3	Százhalombatta
Hungary	Almirall Investigational Sites#8	Zalaegerszeg
Italy	Almirall Investigational Sites#3	Cagliari
Italy	Almirall Investigational Sites#1	Genova
Italy	Almirall Investigational Sites#10	Pisa
Peru	Almirall Investigational Sites#8	Cusco
Poland	Almirall Investigational Sites#12	Bialystok
Poland	Almirall Investigational Sites#9	Bialystok
Poland	Almirall Investigational Sites#19	Elblag
Poland	Almirall Investigational Sites#18	Gdansk
Poland	Almirall Investigational Sites#20	Ilawa
Poland	Almirall Investigational Sites#1	Lodz
Poland	Almirall Investigational Sites#7	Lodz
Poland	Almirall Investigational Sites#8	Lublin
Poland	Almirall Investigational Sites#24	Olsztyn
Poland	Almirall Investigational Sites#5	Olsztyn
Poland	Almirall Investigational Sites#16	Poznan
Poland	Almirall Investigational Sites#21	Poznan
Poland	Almirall Investigational Site#11	Proszowice
Poland	Almirall Investigational Sites#2	Ruda Slaska
Poland	Almirall Investigational Sites#13	Rudka
Poland	Almirall Investigational Sites#4	Sopot
Poland	Almirall Investigational Sites#14	Szczecin
Poland	Almirall Investigational Sites#6	Tarnow
Poland	Almirall Investigational Sites#15	Tarnów
Poland	Almirall Investigational Sites#25	Warszawa
Poland	Almirall Investigational Sites#23	Wilkowice-Bystra
Poland	Almirall Investigational Site#10	Wroclaw
Russian Federation	Almirall Investigational Sites#7	Ekaterinburg
Russian Federation	Almirall Investigational Sites#5	Kazan
Russian Federation	Almirall Investigational Sites#14	Moscow
Russian Federation	Almirall Investigational Sites#2	Moscow
Russian Federation	Almirall Investigational Sites#6	Moscow
Russian Federation	Almirall Investigational Sites#13	Novosibirsk
Russian Federation	Almirall Investigational Sites#10	Saint-Petersburg
Russian Federation	Almirall Investigational Sites#3	Saint-Petersburg
Russian Federation	Almirall Investigational Sites#4	Saint-Petersburg
Russian Federation	Almirall Investigational Sites#12	Tomsk
Russian Federation	Almirall Investigational Sites#8	Tomsk
South Africa	Almirall Investigational Sites#11	Bloemfontein
South Africa	Almirall Investigational Sites#3	Bloemfontein
South Africa	Almirall Investigational Sites#8	Bloemfontein
South Africa	Almirall Investigational Sites#1	Cape Town
South Africa	Almirall Investigational Sites#10	Cape Town
South Africa	Almirall Investigational Sites#12	Cape Town
South Africa	Almirall Investigational Sites#15	Cape Town
South Africa	Almirall Investigational Sites#2	Durban
South Africa	Almirall Investigational Sites#9	George
South Africa	Almirall Investigational Sites#4	Port Elizabeth
South Africa	Almirall Investigational Sites#14	Pretoria
South Africa	Almirall Investigational Sites#5	Pretoria
South Africa	Almirall Investigational Sites#6	Pretoria
Spain	Almirall Investigational Sites#6	Badalona
Spain	Almirall Investigational Sites#7	Barcelona
Spain	Almirall Investigational Sites#8	Barcelona
Spain	Almirall Investigational Sites#3	Madrid
Spain	Almirall Investigational Sites#5	Valencia
Ukraine	Almirall Investigational Sites#4	Donetsk
Ukraine	Almirall Investigational Sites#3	Kharkiv
Ukraine	Almirall Investigational Sites#1	Kyiv
Ukraine	Almirall Investigational Sites#2	Kyiv
Ukraine	Almirall Investigational Sites#7	Kyiv
Ukraine	Almirall Investigational Sites#5	Zaporizhzhya

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Hungary,  Italy,  Peru,  Poland,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment		Baseline and Week 24	No
Primary	Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment		Baseline and Week 12	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment		Baseline and Week 24	No
Secondary	Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment	Number of patients achieving a clinically meaningful improvement (=1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment	Week 24	No
Secondary	Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment	Number of patients who achieved a clinically meaningful improvement (=4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment	Week 24	No

External Links

•   Almirall Corporate Website