Back to resultsA Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arformoterol
levalbuterol
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Respiratory Tract Diseases
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ARF/LEV
LEV/ARF
Arm 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.
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.
Outcomes
Primary Outcome Measures
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).
Change From Predose in Mean Heart Rate
Heart rate measured at various timepoints minus the heart rate at predose.
Mean Systolic Blood Pressure
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).
Change From Predose in Mean Systolic Blood Pressure
Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose
Mean Diastolic Blood Pressure
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).
Change From Predose in Mean Diastolic Blood Pressure
Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure
Mean Serum Potassium Levels
Change From Predose in Mean Serum Potassium
Change in mean serum potassium at the specified timepoint minus the predose value.
Mean Serum Glucose Values
Change From Predose in Mean Serum Glucose
Change in mean serum glucose at the specified timepoint minus the predose value.
Secondary Outcome Measures
Mean Forced Expiratory Volume in One Second(FEV1)
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
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.
Mean Peak Expiratory Flow Rate (PEFR)
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 From Predose in Mean Peak Expiratory Flow Rate (PEFR)
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.
Plasma Concentration of (R,R) Formoterol
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.
Full Information
NCT ID
NCT00583947
First Posted
December 21, 2007
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00583947
Brief Title
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Respiratory Tract Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARF/LEV
Arm Type
Other
Arm 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.
Arm Title
LEV/ARF
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
arformoterol
Other Intervention Name(s)
Brovana
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
levalbuterol
Other Intervention Name(s)
Xopenex
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mean Heart Rate
Description
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).
Time Frame
predose, various timeframes up to 5 hours post last dose
Title
Change From Predose in Mean Heart Rate
Description
Heart rate measured at various timepoints minus the heart rate at predose.
Time Frame
predose, various timeframes up to 5 hours post last dose
Title
Mean Systolic Blood Pressure
Description
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).
Time Frame
predose, various timeframes up to 5 hours post last dose
Title
Change From Predose in Mean Systolic Blood Pressure
Description
Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose
Time Frame
predose, various timeframes up to 5 hours post last dose
Title
Mean Diastolic Blood Pressure
Description
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).
Time Frame
predose, various timeframes up to 5 hours post last dose
Title
Change From Predose in Mean Diastolic Blood Pressure
Description
Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure
Time Frame
predose, various timeframes up to 5 hours post last dose
Title
Mean Serum Potassium Levels
Time Frame
Predose, 2 hours and 6 hours postdose 1
Title
Change From Predose in Mean Serum Potassium
Description
Change in mean serum potassium at the specified timepoint minus the predose value.
Time Frame
predose, 2 and 6 hours post dose
Title
Mean Serum Glucose Values
Time Frame
Predose, 2 and 6 hours post dose 1
Title
Change From Predose in Mean Serum Glucose
Description
Change in mean serum glucose at the specified timepoint minus the predose value.
Time Frame
predose, 2 and 6 hours post dose
Secondary Outcome Measure Information:
Title
Mean Forced Expiratory Volume in One Second(FEV1)
Description
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.
Time Frame
predose, various postdose times
Title
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
Description
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.
Time Frame
predose, various postdose timepoints
Title
Mean Peak Expiratory Flow Rate (PEFR)
Description
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.
Time Frame
predose, various postdose times
Title
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
Description
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.
Time Frame
predose, various postdose times
Title
Plasma Concentration of (R,R) Formoterol
Description
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.
Time Frame
predose, various postdose times
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pulmonary Medical Director
Organizational Affiliation
Unicorn Pharma Consulting
Official's Role
Study Chair
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21584948
Citation
Hinkle J, Hinson J, Kerwin E, Goodwin E, Sciarappa K, Curry L, Hanrahan JP. A cumulative dose, safety and tolerability study of arformoterol in pediatric subjects with stable asthma. Pediatr Pulmonol. 2011 Aug;46(8):761-9. doi: 10.1002/ppul.21446. Epub 2011 May 16.
Results Reference
result
Links:
URL
http://www.xopenex.com/search/searchResult.cfm#precautionsInhalationSolution
Description
Xopenex HCI Patient Prescribing Information
Learn more about this trial
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
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