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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Aclidinium bromide 200 μg bid; Drug: Placebo; Drug: Formoterol 12 μg bid; Drug: Aclidininum bromide 400 μg bid; Drug: Aclidinium bromide 100 μg bid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120093

LAS29

M/34273/29

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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79 participants in 5 patient groups, including a placebo group

Aclidinium bromide 100 μg bid

Experimental group

Description:

Aclidininum bromide 100 μg twice daily by inhalation

Treatment:

Drug: Aclidinium bromide 100 μg bid

Aclidininum bromide 200 μg bid

Experimental group

Description:

Aclidininum bromide 200 μg twice daily by inhalation

Treatment:

Drug: Aclidinium bromide 200 μg bid

Aclidininum bromide 400 μg bid

Experimental group

Description:

Aclidininum bromide 400 μg twice daily by inhalation

Treatment:

Drug: Aclidininum bromide 400 μg bid

Placebo

Placebo Comparator group

Description:

Placebo twice-daily by inhalation

Treatment:

Drug: Placebo

Formoterol 12 μg bid

Active Comparator group

Description:

Formoterol 12 μg twice daily by inhalation

Treatment:

Drug: Formoterol 12 μg bid