A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the dose-response of different doses of CHF 1531 pressurized metered dose inhaler
      (pMDI) containing formoterol fumarate, on lung function and other clinical outcomes and to
      identify the optimal dose(s) with regard to benefit/ risk ratio for further development in
      the target subject population.
    

Detailed description: 
      This is a phase II, randomized, double-blind, placebo and active controlled dose-ranging, 6
      arm incomplete block cross-over study to identify the optimal dose of CHF 1531 pMDI
      (containing formoterol fumarate), with regard to lung function and other clinical efficacy
      and safety outcome measures.

      After a 2 week run-in period under rescue albuterol 'as needed' and background inhaled
      corticosteroid (ICS), subjects qualifying for the study were required to complete 4 treatment
      intervals of 2 weeks each, separated by 2 week wash-out intervals.

      During each treatment interval, the subject were randomly assigned to take one of 5
      double-blind study treatments twice daily (BID) i.e. one of 4 doses of CHF 1531 pMDI or a
      matching placebo or the open-label active control treatment (Perforomist® Inhalation Solution
      [IS]) also BID. During the entire study, all subjects concomitantly received ICS treatment
      with QVAR® inhaler (beclomethasone dipropionate 40 or 80 µg /actuation) twice daily at a dose
      that matches their pre-enrollment ICS and an albuterol inhaler to use as asthma rescue
      medication on 'as needed' basis. The subjects visited the study center every 2 weeks to
      undergo study procedures, and received a safety follow-up phone call one week after their
      last visit. In total, the study lasted 18 weeks and required 10 visits to the study center.

      During the study, daily asthma symptoms, peak expiratory flow, rescue and background
      medication use, and compliance with the study medication were recorded in a subject diary.
      Treatment-Emergent Adverse Events (TEAEs) were assessed and recorded throughout the study. A
      full physical exam, routine hematology, blood chemistry, spirometry, vital signs measurement,
      12-lead ECG, and pregnancy testing were performed before enrollment and at the end of the
      study. Furthermore, on Day 1 and 14 of each treatment interval, serial spirometry, 12-lead
      ECGs, blood pressure measurements (BP), serum potassium, and serum glucose were measured at
      the study center for up to 12 hours post-dose.
    

Intervention name(s): CHF 1531 pMDI; Formoterol Inhalation Solution; Placebo pMDI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose Response: Test one of five different doses of CHF 1531; Active Control; Matched Placebo
Other intervention name(s): PERFOROMIST® 20 μg/ 2 mL vial, 1 vial BID
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other