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Phase 2 Completed N=72 Randomized Triple-blind Treatment

A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

Asthma
Source: ClinicalTrials.gov NCT01058863 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) — 1.21; 1.39; 1.12; 1.33 L*hour — p=<0.0001

Summary

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.

Outcome Measures

OutcomeResultp-value
PRIMARY
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)		 1.21; 1.39; 1.12; 1.33; 0.24 <0.0001 sig
SECONDARY
Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)		 35.31; 41.05; 33.19; 40.68; 7.58 <0.0001 sig
SECONDARY
Participants With Treatment-Emergent Adverse Events		 9; 0; 0; 0; 0; 2 —

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent,
  • Be between 12 years of age and older,
  • Male or Female, females of non-child bearing potential or using reliable contraception
  • Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
  • Stable low dose of Inhaled Corticosteroids
  • Non-smoker, 12 months smoking-free and <=10-pack years history
  • Otherwise healthy
  • Other criteria apply

Exclusion Criteria

  • Pregnant
  • Allergic to albuterol or severe milk protein allergy
  • Must not be on another trial for 30days.
  • Other criteria apply
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01058863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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