Bronchiectasis
Conditions
Interventions
Trade Name: Foster
Product Name: Foster
Pharmaceutical Form: Inhalation powder
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
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% and =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
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. - 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. - Current ICS use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does Formoterol-beclomethasone inhalation in patients with bronchiectasis results in reduction of coughing ;Secondary Objective: Improvement of quality of life reduction in exacerbations 24 hour sputum production (in mL); dyspnea score using Mahler Scale (basal dyspnea index and transition dyspnea index; safety and tolerability of long term formoterol-beclomethasone. local and systemic inflammation ;Primary end point(s): Leicester cough questionnaire;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · To evaluate the improvement of quality of life by Quality of Life Bronchiectasis (QOL-B) questionnaire’s respiratory symptom domain · To evaluate the efficacy of formoterol-beclomethasone on symptoms and pulmonary function (FEV1) and the frequency of exacerbation requiring an intervention with systemic antibiotics (oral/intravenous [i.v.]) in subjects with Bronchiectasis (BE). For this endpoint exacerbation events are defined as events with systemic antibiotic use and worsening of at least one sign/symptom; · To assess the 24 hour sputum production (in mL); · To assess the dyspnea score using the mMRC (Modified Medical Research Council) · To assess the safety and tolerability of long term formoterol-beclomethasone. . To asses local and systemic inflammation;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Netherlands
Contacts
Public Contactresearch longziekten
Erasmus MC
Outcome results
None listed