Randomized,double-blind,placebo-controlled study comparing formoterol-beclometason 12/200 mcg BID versus placebo to evaluate the improvement of coughing and quality of life in subjects with bronchiectasis.

Phase 3

Completed

• Conditions: chronic inflammatory airways; 10024970

• Registration Number: NL-OMON50523
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

· Age >= 18 years;
· 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 if used 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.

Exclusion Criteria

Possible asthma according to the definition of the Global Initiative for Asthma
(GINA) with:
o Positive bronchodilator reversibility test (increase in FEV1 of >12% and
>200 mL from baseline, 10-15 minutes after 200-400 mcg salbutamol or equivalent)
OR
o Positive bronchial challenge test (fall in FEV1from baseline of >=20% with
standard doses of methacholine or histamine)

- Known intolerance for ICS or LABA.
- Current ICS use
- Other cardiopulmonary conditions (other than bronchiectasis) that could
modify spirometric valeus.
- Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
- Cigarette smoking history of > 10 pack-years and/or current smokers;
- Expected to die within 72 hours after enrolment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Leicester cough questionnaire</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of Life Bronchiectasis (QOL-B) questionnaire*s respiratory symptom<br /><br>domain<br /><br>pulmonary function (FEV1)<br /><br>the frequency of exacerbation requiring an intervention with systemic<br /><br>antibiotics (oral/intravenous [i.v.])<br /><br>24 hour sputum production (in mL);<br /><br>dyspnea score using mMRC (Modified Medical Research Council)<br /><br>adverse events<br /><br>Assessing the inflammatory respons by analysing blood and sputum </p><br>