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

February 21, 2012 updated by: Sunovion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
      • Orange, California, United States, 92868
    • Georgia
      • Savannah, Georgia, United States, 31406
    • Illinois
      • Normal, Illinois, United States, 61761
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma City, Oklahoma, United States, 73120
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
      • Spartanburg, South Carolina, United States, 29303
    • Texas
      • Dallas, Texas, United States, 75230
    • Virginia
      • Burke, Virginia, United States, 22015
      • Richmond, Virginia, United States, 23229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ARF/LEV

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.
Drug: arformoterol
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
Drug: levalbuterol
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
Other: LEV/ARF

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.
Drug: arformoterol
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
Drug: levalbuterol
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
predose, various timeframes up to 5 hours post last dose
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.
predose, various timeframes up to 5 hours post last dose
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).
predose, various timeframes up to 5 hours post last dose
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
predose, various timeframes up to 5 hours post last dose
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).
predose, various timeframes up to 5 hours post last dose
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
predose, various timeframes up to 5 hours post last dose
Mean Serum Potassium Levels
Time Frame: Predose, 2 hours and 6 hours postdose 1
Predose, 2 hours and 6 hours postdose 1
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.
predose, 2 and 6 hours post dose
Mean Serum Glucose Values
Time Frame: Predose, 2 and 6 hours post dose 1
Predose, 2 and 6 hours post dose 1
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.
predose, 2 and 6 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
predose, various postdose times
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.
predose, various postdose timepoints
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.
predose, various postdose times
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.
predose, various postdose times
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.
predose, various postdose times

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Investigators

  • Study Chair: Pulmonary Medical Director, Unicorn Pharma Consulting

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091-029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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