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.

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. - FORZA study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50523

Enrollment

Registered

2018-07-06

Start date

2019-01-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic inflammatory airways

Interventions

Formoterol-beclomethasone 12/200 mcg BID versus placebo inhalation dosis aerosol for a period of 3 months

Eligibility

Age

18 Years to 99 Years

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% · 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

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

Design outcomes

Primary

Measure	Time frame
Leicester cough questionnaire	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)