Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
Randomized, double-blind, placebo-controlled study comparing formoterol-beclometason 12/200
 mcg BID versus placebo to evaluate the clinical effect on coughing in patients with
 non-cystic fibrosis (non-CF) bronchiectasis, native to inhaled corticosteroid (ICS) therapy
 and no history of asthma or chronic obstructive pulmonary disease (COPD)
In the management of non-CF bronchiectasis, bronchodilator treatment (LABA)and use of inhaled
 corticosteroids (ICS) is still a matter of debate. Previous studies have claimed beneficial
 effects of ICS (with or without bronchodilator), such as improvement of the HRQL, a reduction
 in daily sputum volume and/or exacerbation frequency. However, in all previous studies there
 was no clear exclusion of patients with asthma or COPD, or no use of placebo. The current
 study will be the first study evaluating the effect of ICS/LABA treatment in non-CF
 bronchiectasis excluding patients with asthma and COPD.

 This is a prospective double-blind randomized controlled trial comparing
 Formoterol-beclomethasone 12/200 mcg BID versus placebo to evaluate the reduction in cough
 measured by the Leicester cough questionnaire. Secondary objectives are the improvement of
 health-related quality of life and symptoms, reduction in sputum production, pulmonary
 function (FEV1) and the frequency of exacerbation. Furthemore, we will assess the
 inflammatory response in serum and sputum.

 After a wash-out period of 1 month, eligible subjects will be randomized to treatment with
 formoterol-beclomethasone or matching placebo. All subjects will be treated with the regimen
 of medication for 3 months. An end-of-study (EOS) visit will be performed after completion of
 the follow-up period.
Inclusion Criteria:

 -  Symptomatic patient (wheezing, cough and dyspnoea);

 -  Proven and documented diagnosis of BE by high resolution computed tomography ;

 -  Stable pulmonary status as indicated by FEV1 (percent of predicted) ≥30%

 -  Stable clinically phase (ie, subjects free from acute exacerbation for at least 6
 weeks prior to the start of the study);

 -  Stable regimen of standard treatment as chronic treatment for BE, at least for the
 past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE
 at least for the past 6 months prior to screening;

 -  Coughing on the majority of days for more than 8 weeks;

 -  Ability to follow the inhaler device instructions;

 -  Ability to complete questionnaires;

 -  Written informed consent.

 Exclusion Criteria:

 -  Possible asthma according to the definition of the Global Initiative for Asthma
 (GINA);

 -  Positive histamine provocation test

 -  Known intolerance for ICS or LABA;

 -  Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;

 -  Expected to die within 72 hours after enrolment;

 -  Cigarette smoking history of > 10 pack-years or current smokers;

 -  Other cardiopulmonary conditions (other than bronchiectasis) that could modify
 spirometric values.