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More info
You can access this
clinical trial
if you have
Asthma
and you are
between 5 and 11
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

The purpose of this clinical study is to compare the improvement in breathing of single administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose 100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg) given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children. Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to placebo and the effect on other lung function parameters, to assess the safety and tolerability of CHF 1535 dosages in children.

Provided treatments

  • Drug: beclomethasone+formoterol 50/6 (1 inhalation)
  • Drug: CHF 1535 50/6 (2 inhalations)
  • Drug: CHF 1535 50/6 (4 inhalations)
  • Drug: Formoterol + Beclomethasone dipropionate
  • Drug: Placebo (6 inhalations)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01584492. The sponsor of the trial is Chiesi Farmaceutici S.p.A. and it is looking for 59 volunteers for the current phase.
Official trial title:
Double Blind, Double Dummy, Cross-over Study to Compare the Bronchodilator Effect of CHF1535 pMDI (Fixed Combination of Beclometasone 50 µg + Formoterol 6 µg) Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children