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

NCT00583947 | Completed Phase 2 Results

• 1 other identifier: 091-029
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (10)

• 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).

  predose, various timeframes up to 5 hours post last dose

• Change From Predose in Mean Heart Rate

  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

  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

  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

  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

  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

  Predose, 2 hours and 6 hours postdose 1

• Change From Predose in Mean Serum Potassium

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

  predose, 2 and 6 hours post dose

• Mean Serum Glucose Values

  Predose, 2 and 6 hours post dose 1

• Change From Predose in Mean Serum Glucose

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

  predose, 2 and 6 hours post dose

Secondary Outcomes (5)

• Mean Forced Expiratory Volume in One Second(FEV1)

  predose, various postdose times

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

  predose, various postdose timepoints

• Mean Peak Expiratory Flow Rate (PEFR)

  predose, various postdose times

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

  predose, various postdose times

• Plasma Concentration of (R,R) Formoterol

  predose, various postdose times

Study Arms (2)

ARF/LEV

OTHER

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; Drug: levalbuterol

LEV/ARF

OTHER

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; Drug: levalbuterol

Interventions

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).

Also known as: Brovana

ARF/LEV; LEV/ARF

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).

Also known as: Xopenex

ARF/LEV; LEV/ARF

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (14)

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Savannah, Georgia, 31406, United States

Location

Unknown Facility

Normal, Illinois, 61761, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73112, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73120, United States

Location

Unknown Facility

Medford, Oregon, 97504, United States

Location

Unknown Facility

Portland, Oregon, 97213, United States

Location

Unknown Facility

Upland, Pennsylvania, 19013, United States

Location

Unknown Facility

Orangeburg, South Carolina, 29118, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Burke, Virginia, 22015, United States

Location

Unknown Facility

Richmond, Virginia, 23229, United States

Location

Related Publications (1)

• 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.

  PMID: 21584948 RESULT

MeSH Terms

Conditions

Asthma; Respiratory Tract Diseases

Interventions

Formoterol Fumarate; Levalbuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Albuterol; Phenethylamines; Ethylamines

Limitations and Caveats

Sample size was determined outside of statistical considerations. All data recorded at/after Visit 8 for 6 subjects, misdosed with ARF 7.5mcg instead of ARF 15mcg in open-label period, were excluded from the planned efficacy, PK and safety analyses.

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sepracor Inc

866-503-6351

Study Officials

• Pulmonary Medical Director

  Unicorn Pharma Consulting

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 22, 2012
• Results First Posted: February 8, 2010

Record last verified: 2012-01

Locations

US (14)