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

NCT ID: NCT01844401

Last Updated: 2013-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-10-31

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.

Detailed Description

This is a single center, open-label, 2-period crossover study. The study consists of a screening visit followed by a treatment period comprising 2 treatment visits. The treatment period visits will be separated by a 4 to 14-day washout period. Eligible patients will be kept overnight prior to each treatment period.

Conditions

Asthma

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spiromax/ProAir

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

Group Type: EXPERIMENTAL

Albuterol Spiromax®

Intervention Type: DRUG

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

ProAir® HFA

Intervention Type: DRUG

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

ProAir/Spiromax

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

Group Type: EXPERIMENTAL

Albuterol Spiromax®

Intervention Type: DRUG

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

ProAir® HFA

Intervention Type: DRUG

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

Interventions

Albuterol Spiromax®

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

Intervention Type: DRUG

ProAir® HFA

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

Intervention Type: DRUG

Other Intervention Names

Spiromax®; ProAir®

Eligibility Criteria

Inclusion Criteria

1. Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study-related procedure.

2. Male or pre-menarchal female patient 4-11 years of age, inclusive, as of the Screening Visit (SV)

3. 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).

4. 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.

5. 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

6. Has required less than 4 inhalations per week of a rescue bronchodilator (on average) for the 4 weeks preceding the SV

7. 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

Exclusion Criteria

1. A known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (lactose, ethanol, etc.)

2. 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

3. History of severe milk protein allergy

4. Proneness to orthostatic dysregulation, syncope, or blackouts

5. 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.

6. 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

7. 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teva Investigational Site 10538

Costa Mesa, California, United States

Countries

United States

Other Identifiers

ABS-AS-102

Identifier Type: -

Identifier Source: org_study_id