Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE1
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 e...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01844401
Start Date
April 1 2013
End Date
October 1 2013
Last Update
November 14 2013
Active Locations (1)
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1
Teva Investigational Site 10538
Costa Mesa, California, United States