Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

NCT ID: NCT01120093

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-08-31

Brief Summary

The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aclidinium bromide 100 μg bid

Aclidininum bromide 100 μg twice daily by inhalation

Group Type: EXPERIMENTAL

Aclidinium bromide 100 μg bid

Intervention Type: DRUG

Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Aclidininum bromide 200 μg bid

Aclidininum bromide 200 μg twice daily by inhalation

Group Type: EXPERIMENTAL

Aclidinium bromide 200 μg bid

Intervention Type: DRUG

Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Aclidininum bromide 400 μg bid

Aclidininum bromide 400 μg twice daily by inhalation

Group Type: EXPERIMENTAL

Aclidininum bromide 400 μg bid

Intervention Type: DRUG

Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Placebo

Placebo twice-daily by inhalation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo via inhalation in the morning and evening for 7 days

Formoterol 12 μg bid

Formoterol 12 μg twice daily by inhalation

Group Type: ACTIVE_COMPARATOR

Formoterol 12 μg bid

Intervention Type: DRUG

Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days

Interventions

Aclidinium bromide 100 μg bid

Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Intervention Type: DRUG

Aclidinium bromide 200 μg bid

Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Intervention Type: DRUG

Aclidininum bromide 400 μg bid

Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Intervention Type: DRUG

Placebo

Placebo via inhalation in the morning and evening for 7 days

Intervention Type: DRUG

Formoterol 12 μg bid

Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and non-pregnant, non-lactating females aged ≥ 40.

2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).

3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.

4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of salbutamol is 30% < FEV1 <80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).

5. Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.

6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria

1. History or current diagnosis of asthma.

2. Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature

3. Hospitalisation due to COPD exacerbation within the previous 3 months.

4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.

5. Clinically significant cardiovascular conditions

6. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.

7. Presence of narrow-angle glaucoma.

8. QTcB) above 470 milliseconds in the ECG performed at Screening Visit,

9. Patient who does not maintain regular day/night, waking/sleeping cycles

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Garcia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Almirall Investigational Sites#1

Ghent, , Belgium

Almirall Investigational Sites#3

Berlin, , Germany

Almirall Investigational Sites#4

Berlin, , Germany

Almirall Investigational Sites#9

Berlin, , Germany

Almirall Investigational Sites#8

Frankfurt, , Germany

Almirall Investigational Sites#1

Groβhansdorf, , Germany

Almirall Investigational Sites#5

Hamburg, , Germany

Almirall Investigational Sites#7

Hanover, , Germany

Almirall Investigational Sites#2

Hanover, , Germany

Almirall Investigational Sites#6

Schwerin, , Germany

Almirall Investigational Sites#10

Wiesbaden, , Germany

Countries

Belgium; Germany

References

Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4.

Reference Type: DERIVED

PMID: 22497752 (View on PubMed)

Related Links

http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp

Almirall Corporate Website

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3977&filename=Synopsis_m-34273-29-Final.pdf

CSR Synopsis

Other Identifiers

LAS29

Identifier Type: -

Identifier Source: secondary_id

M/34273/29

Identifier Type: -

Identifier Source: org_study_id