Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462929
• Other study ID #: M/34273/39
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2011
• Last updated: May 28, 2015
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: May 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 aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• 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
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
• Tiotropium
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 µg) in the morning (09:00 ± 1h)
• Placebo
Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).

Locations

Country	Name	City	State
Czech Republic	Almirall Investigational Site #9	Humpolec
Czech Republic	Almirall Investigational Site #1	Jaromer
Czech Republic	Almirall Investigational Site #3	Melnik
Germany	Almirall Investigational Site #10	Berlin
Germany	Almirall Investigational Site #12	Berlin
Germany	Almirall Investigational Site #2	Berlin
Germany	Almirall Investigational Site #20	Berlin
Germany	Almirall Investigational Site #21	Berlin
Germany	Almirall Investigational Site #4	Berlin
Germany	Almirall Investigational Site #8	Berlin
Germany	Almirall Investigational Site #13	Dresden
Germany	Almirall Investigational Site #9	Frankfurt
Germany	Almirall Investigational Site #3	Grosshansdorf
Germany	Almirall Investigational Site #1	Hamburg
Germany	Almirall Investigational Site #18	Hamburg
Germany	Almirall Investigational Site #22	Hannover
Germany	Almirall Investigational Site #5	Hannover
Germany	Almirall Investigational Site #14	Jena
Germany	Almirall Investigational Site #24	Koln
Germany	Almirall Investigational Site #17	Lubeck
Germany	Almirall Investigational Site #23	Rudersdorf
Germany	Almirall Investigational Site #6	Schwerin
Germany	Almirall Investigational Site #16	Wiesbaden
Hungary	Almirall Investigational Site #4	Debrecen
Hungary	Almirall Investigational Site #2	Komarom
Hungary	Almirall Investigational Site #3	Matrahaza
Hungary	Almirall Investigational Site #1	Szarvas
Hungary	Almirall Investigational Site #11	Szigetszentmiklos
Poland	Almirall Investigational Site #18	Bialystok
Poland	Almirall Investigational Site #8	Bialystok
Poland	Almirall Investigational Site #2	Elblag
Poland	Almirall Investigational Site #10	Krakow
Poland	Almirall Investigational Site #17	Krakow
Poland	Almirall Investigational Site #16	Lodz
Poland	Almirall Investigational Site #20	Lodz
Poland	Almirall Investigational Site #4	Proszowice
Poland	Almirall Investigational Site #6	Sopot
Poland	Almirall Investigational Site #14	Tarnow
Poland	Almirall Investigational Site #19	Warszawa
Poland	Almirall Investigational Site #12	Wilkowice-Bystra
Poland	Almirall Investigational Site #13	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment	Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.	Week 6	No
Secondary	Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment	Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.	Week 6	No