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Related Experiment Videos

Flunisolide HFA.

John Waugh1, Karen L Goa

  • 1Adis International Inc., Langhorne, Pennsylvannia 19047, USA. demail@adis.com

American Journal of Respiratory Medicine : Drugs, Devices, and Other Interventions
|January 15, 2004
PubMed
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A new hydrofluoroalkane (HFA) flunisolide inhaler offers improved lung deposition and similar asthma treatment efficacy at a lower dose compared to older chlorofluorocarbon (CFC) inhalers. This HFA formulation is well-tolerated with minimal systemic effects.

Area of Science:

  • Pulmonology
  • Pharmacology
  • Respiratory Medicine

Background:

  • Flunisolide, a synthetic corticosteroid, treats persistent asthma via metered-dose inhalers (MDIs).
  • Chlorofluorocarbon (CFC) propellants are being phased out globally due to ozone depletion.
  • A new hydrofluoroalkane (HFA) propellant formulation for flunisolide MDIs has been developed.

Purpose of the Study:

  • To evaluate the efficacy and safety of a new flunisolide HFA MDI formulation.
  • To compare the new HFA formulation with the existing flunisolide CFC MDI and placebo.
  • To assess the impact of formulation changes on aerosol properties and lung deposition.

Main Methods:

  • A randomized, double-blind, placebo-controlled, 12-week study.
  • Patients with mild to moderate asthma received flunisolide HFA (170/340 µg BID), flunisolide CFC (500/1000 µg BID), or placebo.

Related Experiment Videos

  • Aerosol particle size and lung deposition were analyzed.
  • Adrenal function and systemic effects were monitored in long-term studies.
  • Main Results:

    • Flunisolide HFA MDI produced smaller aerosol particles (1.2 µm MMAD) compared to CFC suspension (3.8 µm MMAD).
    • The HFA formulation demonstrated similar efficacy to the CFC formulation at one-third the dose.
    • Significantly greater efficacy than placebo was observed for flunisolide HFA.
    • Improved distal lung deposition was noted with the HFA MDI, featuring a redesigned built-in spacer.
    • Flunisolide HFA was well-tolerated, with no adrenal suppression and minimal systemic effects in adults and children.

    Conclusions:

    • The new flunisolide HFA MDI formulation is an effective and safe alternative to CFC-based inhalers for persistent asthma.
    • The HFA formulation offers improved lung deposition and efficacy at reduced dosages.
    • This environmentally friendly formulation supports the phase-out of ozone-depleting propellants.