Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial

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Brief Title

Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial

Official Title

Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial

Brief Summary

      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)
    

Detailed Description

      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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Clinical effect on coughing

Secondary Outcome

 Quality of life in patient with bronchiectasis

Condition

Bronchiectasis

Intervention

Formoterol-beclomethasone

Study Arms / Comparison Groups

 Formoterol-beclomethasone
Description:  Formoterol (fumarate dehydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

72

Start Date

January 29, 2019

Completion Date

December 2019

Primary Completion Date

December 2019

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Menno M Van der Eerden, +31107030323, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT03846570

Organization ID

NL61630.078.18


Responsible Party

Principal Investigator

Study Sponsor

Erasmus Medical Center

Collaborators

 Chiesi Farmaceutici S.p.A.

Study Sponsor

Menno M Van der Eerden, Principal Investigator, Erasmus Medical Center


Verification Date

February 2019