Skip to main content
OpenTrials
Completed

NCT Number: NCT00583947

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beverly Hills, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arformoterol

Drug

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).

Other names: Brovana

Levalbuterol

Drug

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).

Other names: Xopenex

Primary outcomes

  1. Mean Heart Rate

    Time frame: predose, various timeframes up to 5 hours post last dose

    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).

  2. Change From Predose in Mean Heart Rate

    Time frame: predose, various timeframes up to 5 hours post last dose

    Heart rate measured at various timepoints minus the heart rate at predose.

  3. Mean Systolic Blood Pressure

    Time frame: predose, various timeframes up to 5 hours post last dose

    Systolic blood pressure 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).

  4. Change From Predose in Mean Systolic Blood Pressure

    Time frame: predose, various timeframes up to 5 hours post last dose

    Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose

  5. Mean Diastolic Blood Pressure

    Time frame: predose, various timeframes up to 5 hours post last dose

    Diastolic blood pressure 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).

  6. Change From Predose in Mean Diastolic Blood Pressure

    Time frame: predose, various timeframes up to 5 hours post last dose

    Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure

  7. Mean Serum Potassium Levels

    Time frame: Predose, 2 hours and 6 hours postdose 1

  8. Change From Predose in Mean Serum Potassium

    Time frame: predose, 2 and 6 hours post dose

    Change in mean serum potassium at the specified timepoint minus the predose value.

  9. Mean Serum Glucose Values

    Time frame: Predose, 2 and 6 hours post dose 1

  10. Change From Predose in Mean Serum Glucose

    Time frame: predose, 2 and 6 hours post dose

    Change in mean serum glucose at the specified timepoint minus the predose value.

Secondary outcomes

  1. Mean Forced Expiratory Volume in One Second(FEV1)

    Time frame: predose, various postdose times

    Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.

  2. Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)

    Time frame: predose, various postdose timepoints

    Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.

  3. Mean Peak Expiratory Flow Rate (PEFR)

    Time frame: predose, various postdose times

    PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.

  4. Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)

    Time frame: predose, various postdose times

    PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.

  5. Plasma Concentration of (R,R) Formoterol

    Time frame: predose, various postdose times

    If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

A Cumulative Dose Safety and Tolerability Crossover Study of Arformoterol Tartrate Inhalation Solution and Levalbuterol Hydrochloride Inhalation Solution in Pediatric Subjects (Aged 2 to 11 Years of Age) With Asthma

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 2, 2008
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.