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

Sumitomo Pharma

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: arformoterol; Drug: levalbuterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00583947

091-029

Details and patient eligibility

About

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

Full description

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.

Enrollment: 53 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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53 participants in 2 patient groups

ARF/LEV

Other group

Description:

Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

Treatment:

Drug: levalbuterol

Drug: arformoterol

LEV/ARF

Other group

Description:

Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

Treatment:

Drug: levalbuterol

Drug: arformoterol