A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

Sumitomo Pharma America, Inc.53 enrolled

Overview

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

arformoterolDRUG

Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

levalbuterolDRUG

Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Eligibility

Sex: ALLMin age: 2 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and Female * Between Age 2 and 11, inclusive, at the time of consent * Weight equal to or greater than 15 Kg * History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger. Exclusion Criteria: * Female subject who is pregnant or lactating. * Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial. * Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures. * Subject with a history of cancer. * Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders. * Subject with a history of cigarette smoking or use of any tobacco products.

Locations (14)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

Orange, California, United States

Unnamed facility

Savannah, Georgia, United States

Outcomes

Primary Outcomes

Mean Heart Rate

Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).