Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg
      HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed
      combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi
      Farmaceutici) in terms of Pulmonary Function (morning PEF).
    

Detailed description: 
      Asthma is a chronic inflammatory disorder of the airways and a serious public health
      worldwide problem, affecting people of all ages, with an estimate of 300 millions affected
      individuals.When uncontrolled, asthma can place severe limits on daily life, and can
      sometimes be fatal.

      There are two major classes of inhaled therapy for the treatment of reversible obstructive
      airways disease: antinflammatory agents and bronchodilators. In particular, BDP 250 mcg plus
      salbutamol 100 mcg in fixed combination is an effective and safe method to control symptoms
      of persistent asthma in adults.

      This study has been designed to compare the efficacy, safety and tolerability of a new BDP
      250 mcg/salbutamol 100 mcg HFA pMDI fixed combination with the same CFC-formulated fixed
      combination, which is on the market from some decades.The HFA propelled product is developed
      to replace the CFC formulation already marketed according to the European Union's Committee
      for Proprietary Medicinal Products (CPMP) Note for Guidance (III/5378/93 - Final) in order to
      prevent from depletion of stratospheric ozone.

      The primary objective of this trial is to demonstrate that the test treatment BDP 250
      mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol
      100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum
      250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).

      Given the aim of the study, the population to be monitored includes adult patients with
      persistent asthma according to the current guidelines. The treatment period will be preceded
      by a 2-week run-in period. Subjects satisfying all the inclusion and exclusion criteria will
      then enter the 12-week treatment period. Clinic visits will take place at the start and end
      of the run-in period, and after 2, 4, 8 and 12 weeks after randomisation.
    

Intervention name(s): salbutamol 100 mcg; BDP/salbutamol HFA pMDI; BDP/salbutamol CFC pMDI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): To be used as needed for symptom relief; Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo; Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo
Other intervention name(s): Ventolin®; Clenil® Compositum 250
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: beclomethasone; as needed; salbutamol; wheezing