{
  "abstract": "Background Growing concern around the global warming potential (GWP) of hydrofluoroalkane 134a (HFA-134a) propellant used in pressurized metered dose inhaler (pMDI) for asthma and COPD has prompted research into alternatives like HFA-152a, with a significantly lower GWP.A new formulation of CHF1535 [beclometasone dipropionate (BDP)/formoterol fumarate (FF)] 100/6 µg medium strength (MS) and 200/6 µg high strength (HS) has been developed with HFA-152a. Bioequivalence with CHF1535 HFA-134a marketed formulation should be demonstrated for BDP, B17MP (active metabolite of BDP) and Formoterol.Methods Two single-dose, double-blind, randomized, 4-way crossover studies with CHF1535 MS or HS were conducted in healthy volunteers, administered with a single dose of 4 inhalations of each formulation with HFA-152a or HFA-134a, with and without the use of the AeroChamber Plus ® spacer. Primary PK endpoints were Cmax, AUC0-t and tmax for all analytes and AUC0–30 min for Formoterol only, to assess lung availability and systemic effect. Safety was monitored.Results The 90% confidence intervals of all PK parameter ratios between HFA-152a and HFA-134a for lung availability and total systemic exposure were within the bioequivalence acceptance interval (80.00–125.00%) for both strengths, with and without the spacer. There was no shift in median t max. No safety signals were observed.Conclusions Therapeutic equivalence between the two formulations was demonstrated, supporting the timely introduction of therapeutic options enabling a seamless transition for patients, while minimizing climate impact.",
  "authors": [
    {
      "affiliations": [
        "Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "M Almeida"
    },
    {
      "affiliations": [
        "Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "M Salvadori"
    },
    {
      "affiliations": [
        "University of Parma, Parma, Italy"
      ],
      "name": "M Corradi"
    },
    {
      "affiliations": [
        "SGS Belgium NV, Clinical Pharmacology Unit, Edegem, Italy"
      ],
      "name": "T De Ridder"
    },
    {
      "affiliations": [
        "SGS Belgium NV, Clinical Pharmacology Unit, Edegem, Italy"
      ],
      "name": "N Praet"
    },
    {
      "affiliations": [
        "Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "I Viaud"
    },
    {
      "affiliations": [
        "Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "G Varoli"
    },
    {
      "affiliations": [
        "Alira Health S.r.l, Milan, Italy"
      ],
      "name": "L Girardello"
    },
    {
      "affiliations": [
        "AIR Pipeline Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "F Sandri"
    },
    {
      "affiliations": [
        "Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "G Cappellini"
    },
    {
      "affiliations": [
        "Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "LV Viganò"
    },
    {
      "affiliations": [
        "Global Clinical Development, Chiesi USA Inc, Cary, NC, USA"
      ],
      "name": "KS Mathews"
    },
    {
      "affiliations": [
        "Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy"
      ],
      "name": "G Poli"
    }
  ],
  "title": "P6 Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant",
  "uid": "d657c5e8-4714-5524-b0ab-818e0aa904f6"
}