Efficacy and safety study of two fixed-dose combinations of aclidinium bromide with Formoterol Fumarate compared with aclidinium bromide, Formoterol Fumarate and placebo - LAC-MD-27

Study identifier:LAC-MD-27

ClinicalTrials.gov identifier:NCT01049360

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 2

Healthy volunteers

Study drug

Aclidinium 400 μg / Formoterol 12 μg, Aclidinium 400 μg / Formoterol 6 μg, Aclidinium 400 μg, Formoterol 12 μg, Placebo

Sex

All

Actual Enrollment

128

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Dec 2009

Primary Completion Date: 01 Aug 2010

Study Completion Date: 01 Aug 2010

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2017 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Understand the study procedures and be willing to participate in the study as
indicated by signing the ICF and HIPAA form
- Be male or female aged 40 to 80 years, inclusive
- Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by
guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
- Be a current or former cigarette smoker with a smoking history of at least
10 pack-years
- Have post–albuterol/salbutamol FEV1 values ≥ 30% and < 80% of the predicted
value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and
15 minutes after inhalation of albuterol/salbutamol.
- Have post–albuterol/salbutamol FEV1/FVC values < 70% (ie, 100 × post–
albuterol/salbutamol FEV1/FVC < 70%).
- If female, be at least 1 year postmenopausal or surgically sterile (defined as having a
hysterectomy or tubal ligation). Women of childbearing potential must have a
negative serum β-human chorionic gonadotropin pregnancy test at screening
- Be in good stable health (as judged by the Investigator) other than the COPD, based
on medical history, physical examination, ECG, spirometry, and clinical laboratory
data evaluations
- Have COPD symptoms and FEV1 values at the time of randomization that are stable
compared with those at Screening (Visit 1), according to the Investigator’s medical
judgment

Exclusion Criteria

- Have been hospitalized for an acute COPD exacerbation within 3 months before
screening
- Have any respiratory tract infection (including the upper respiratory tract) or signs of
a COPD exacerbation or respiratory infection in the 6 weeks before Screening
(Visit 1).
- Have any clinically significant respiratory conditions other than COPD
- Have a history or presence of asthma verified from medical records
- Have used theophylline (including long-acting theophylline) within the previous
3 months before study entry
- Have Stage II hypertension, defined as systolic pressure of 160 and above, and
diastolic pressure of 100 and above
- Chronic use of oxygen therapy ≥ 15 hours a day
- Have a history, current diagnosis, or presence of exercise-induced bronchospasm
- Have a body mass index ≥ 40 kg/m2
- Have participated in an pulmonary rehabilitation program within the previous
3 months
- Have clinically significant cardiovascular conditions
- Have uncontrolled infection resulting from human immunodeficiency virus and/or
active hepatitis
- Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.
- Have narrow-angle glaucoma
- Have a history of hypersensitivity reaction (including report of paradoxical
bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2
adrenergic agonists, or any other inhaled medication or any component thereof
- Have a QTcB, as indicated in the centralized reading report, above 470 msec in the
resting ECGs performed at Screening (Visit 1) and/or patients who are using
medications that may prolong the QT interval
- Have clinically relevant abnormalities in the results of clinical laboratory tests, in
ECG parameters other than QTc, in results of the physical examination,
- Have any concurrent medical condition that, in the judgment of the Investigator,
might interfere with the conduct of the study, confound the interpretation of the study
results, or endanger the patient’s well-being
- Do not maintain regular day/night, waking/sleeping cycles (eg, patients with history
of sleep apnea syndrome or any disease related with sleep disturbances such as
restless legs syndrome or somnambulism)

No locations available

Arms	Assigned Interventions
Experimental: Aclidinium 400 μg / Formoterol 12 μg Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)	Drug: Aclidinium 400 μg / Formoterol 12 μg Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Experimental: Aclidinium 400 μg / formoterol 6 μg Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)	Drug: Aclidinium 400 μg / Formoterol 6 μg Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Experimental: Aclidinium 400 μg Aclidinium bromide 400 μg administered twice-daily (BID)	Drug: Aclidinium 400 μg Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
Active Comparator: Formoterol 12 μg Formoterol fumarate 12 μg twice-daily	Drug: Formoterol 12 μg Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
Placebo Comparator: Placebo Placebo twice-daily	Drug: Placebo Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Documents available

lac-md-27-synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Esther Garcia

AstraZeneca