Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma

NCT01844401 | Completed Phase 1

• 1 other identifier: ABS-AS-102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the pharmacokinetic (PK) profiles of Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg albuterol base from each product.

Conditions

Asthma

Keywords

persistent asthma; Albuterol Spiromax®; ProAir® HFA; Pediatric Patients; Phase 1

Outcome Measures

Primary Outcomes (2)

• Area under the plasma albuterol concentration-time curve

  Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.

  Time 0 to the last detectable plasma albuterol concentration measured up to 10 hours post-dose (AUC0-t)

• Maximum observed plasma albuterol concentration (Cmax)

  Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.

  From baseline to up to 10 hours post dose

Secondary Outcomes (2)

• Pharmacodynamic Effect on Vital Signs

  From baseline to up to 6 hours post dose

• Summary of participants with adverse events

  From Day 1 to end of Follow-up Visit (approximately 4 weeks)

Study Arms (2)

Spiromax/ProAir

EXPERIMENTAL

Single dose of Albuterol Spiromax® 180 mcg followed by a 4 to 14 day washout period then a single dose of ProAir® HFA 180 mcg

Drug: Albuterol Spiromax®; Drug: ProAir® HFA

ProAir/Spiromax

EXPERIMENTAL

Single dose of ProAir® HFA 180 mcg followed by a 4 to 14 day washout period then a single dose of Albuterol Spiromax® 180 mcg

Drug: Albuterol Spiromax®; Drug: ProAir® HFA

Interventions

Albuterol Spiromax® DRUG

Albuterol Spiromax® 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose

Also known as: Spiromax®

ProAir/Spiromax; Spiromax/ProAir

ProAir® HFA DRUG

ProAir® HFA 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose

Also known as: ProAir®

ProAir/Spiromax; Spiromax/ProAir

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study-related procedure.
• Male or pre-menarchal female patient 4-11 years of age, inclusive, as of the Screening Visit (SV)
• Has a documented physician diagnosis of persistent asthma of a minimum of 3 months duration that has been stable for at least 4 weeks prior to the SV. The asthma diagnosis must be in accordance with the National Asthma Education and Prevention Program Guidelines Expert Panel Report 3 (EPR3).
• Forced expiratory volume in 1 second (FEV1) \>80% predicted for age, height and gender and race at the SV based on the pediatric population standards.
• Any patient being treated with inhaled corticosteroids (ICS) must be on a lowdose regimen (200 mcg or less of fluticasone propionate per day or equivalent), which has been stable for at least 4 weeks prior to the SV and which is expected to be maintained for the duration of the study
• Has required less than 4 inhalations per week of a rescue bronchodilator (on average) for the 4 weeks preceding the SV
• Has the ability to withhold inhaled albuterol for at least 72 hours preceding each Treatment Visit (TV).
• Other criteria apply, including must weigh at least 45 pounds

You may not qualify if:

• A known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (lactose, ethanol, etc.)
• Participation (receiving study drug) in any investigational drug trial within the 30 days preceding the SV or planned participation in another investigational drug trial at any time during this trial
• History of severe milk protein allergy
• Proneness to orthostatic dysregulation, syncope, or blackouts
• History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza) that has not resolved within 2 weeks preceding the SV.
• History of life-threatening asthma or that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures
• Any asthma exacerbation requiring systemic corticosteroids within 3 months of the SV. A patient must not have had any hospitalization for asthma within 6 months prior to the SV.
• Other criteria apply.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (1)

Teva Investigational Site 10538

Costa Mesa, California, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Procaterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

US (1)