Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease; Emphysema; Bronchitis

Treatments: Drug: Formoterol 12 ųg BID; Drug: Placebo; Drug: Arformoterol tartrate inhalation solution; Drug: Arformoterol 25 ųg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT00250679

091-061

Details and patient eligibility

About

To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).

Full description

This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD. Study participation will be over approximately 6 months. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Enrollment: 443 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male and female subjects must be at least 35 years old at the time of consent
• Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD
• Subjects must have a >=15 pack-year smoking history and a baseline breathlessness severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visits 1 and 2
• Female subjects <=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control
• Subjects must be in general good health.

Key Exclusion criteria:

• Subjects with a history of asthma, with the exception of asthma diagnosed in childhood
• Subjects with a blood eosinophil count >5% of total white blood cell count
• Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1
• Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

443 participants in 3 patient groups

Formoterol 12 ųg 2x/day

Active Comparator group

Treatment:

Drug: Placebo

Drug: Formoterol 12 ųg BID

Arformoterol 15 ųg 2x/day

Experimental group

Treatment:

Drug: Placebo

Drug: Arformoterol tartrate inhalation solution

Arformoterol 25 ųg 2x/day

Experimental group

Treatment:

Drug: Placebo

Drug: Arformoterol 25 ųg BID