Fine Particle pMDI Formoterol/Beclomethasone in Asthmatics With and Without Spacer: Comparative Efficacy Evaluation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered
      dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of
      different types and sizes have also been developed for use in combination with pMDI. The
      therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers
      can optimize lung deposition as it obviates lung-hand coordination and retain larger
      particles. The aim of this study is to compare the efficacy of the fine particle combination
      pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a spacer in
      patients without adequate asthma control on medium to high-dose inhaled steroids associated
      with long acting beta adrenergic drugs. The hypothesis is that there is no clinical efficacy
      difference between the two forms of drug administration.
    

Detailed description: 
      This is a randomized, parallel controlled study with blind outcome evaluation to compare the
      efficacy of the fine particle combination Beclomethasone/Formoterol administered with or
      without valved holding chamber (Vortex, Pari Innovative Manufacturers, VA - USA.

      Eligible asthma patients will begin a 2-weeks run-in period to optimize their control
      medication use and to learn the correct relief pMDI use without holding chamber. After the
      run-in, patients with non-controled asthma symptoms (ACT score 19 or under)in spite the use
      of medium to high dose inhaled steroids and LABA association and able to use correctly the
      pMDI will be randomized (block-randomization) to receive the test medication combination to
      be used with or without the spacer device (VORTEX). Patients will be evaluated after 30 and
      60 days. At days 15 (+,- 2) and 45 (+,- 2) they will have an incentive phone call.

      ACT score (translated and validated to portuguese - Brazil), FEV1 (Kit-Micro spirometer,
      Cosmed, Italy), pMDI use and clinical evaluation will be obtained at initial visit (visit 0),
      randomization visit (visit 1)and at 30 and 60 days (visits 2 and 3). Extra-medication allowed
      at run-in period will be inhaled beta-2 bronchodilators for relief an at treatment period
      inhaled beta-2 agonists for relief and systemic steroids for exacerbations, with antibiotics
      as needed.

      Endpoint evaluations will be proceeded by a treatment blinded investigator.In order to keep
      the concealment, the evaluations will be held in a different room and the patients instructed
      not to comment on treatment.

      Subjects will be excluded at the treatment period in case of severe asthma exacerbation
      (hospital or ICU recovery or systemic steroid used for more than 5 days). They will be
      excluded also in case of concomitant ailments at discretion of the attending physician. These
      patients will be excluded from the per-protocol evaluation but will be described.

      Sample size was calculated taking into account a relevant ACT score difference of 3 points
      and a SD of 4.4 (SCHATZ M et all. Asthma Control Test: reliability, validity, and
      responsiveness in patients not previously followed by asthma specialists. J Allergy Clin
      Immunol 2006;117:549-56). In order to be able to detect this difference with α and β errors
      of 5% and 20% respectively, the investigators calculated 32 patients per group.

      Statistical analysis will be carried according to data distribution by a professional
      statistician.
    

Intervention name(s): Spacer; Comparator
Intervention type(s): Device; Device
Intervention description(s): Beclomethasone/Formoterol 100/6mcg pMDI 2 puffs two times/day with the aid of a Valved Holding Chamber - VORTEX; Beclomethasone/Formoterol 100/6mcg pMDI 2 puffs two times/day without the aid of a Valved Holding Chamber - VORTEX
Other intervention name(s): BECLOMETHASONE EXTRA-FINE; FORMOTEROL; FOSTAIR; INNOVAIR; VORTEX
Intervention MeSH terms: Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Asthma; pMDI; Beclomethasone; Formoterol; Efficacy