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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120093
• Other study ID #: M/34273/29
• Secondary ID: LAS29
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2010
• Last updated: May 28, 2015
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover 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 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
• 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
• 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
• Placebo
Placebo via inhalation in the morning and evening for 7 days
• 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

Locations

Country	Name	City	State
Belgium	Almirall Investigational Sites#1	Gent
Germany	Almirall Investigational Sites#3	Berlín
Germany	Almirall Investigational Sites#4	Berlín
Germany	Almirall Investigational Sites#9	Berlín
Germany	Almirall Investigational Sites#8	Frankfurt
Germany	Almirall Investigational Sites#1	Großhansdorf
Germany	Almirall Investigational Sites#5	Hamburg
Germany	Almirall Investigational Sites#2	Hannover
Germany	Almirall Investigational Sites#7	Hannover
Germany	Almirall Investigational Sites#6	Schwerin
Germany	Almirall Investigational Sites#10	Wiesbaden

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment		Day 7	No
Secondary	Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment		Day 7	No
Secondary	Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment		Day 7	No
Secondary	Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment		Day 7	No

External Links

•   Almirall Corporate Website