RecruitingPhase 2

VENTURI (VENTilation Using Respiratory Imaging)

Open-label, Prospective, Crossover, Proof-of-concept Study to Evaluate the Effect of Triple Therapy With Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate (BDP/FF/G) Via pMDI Compared With Non-extrafine Fluticasone Furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI) Via DPI on Lung Ventilation and Clinical Outcomes in Subjects With Moderate to Severe Asthma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will comprise of 5 visits."
  • "At the randomization visit (V2, Week 0), patients will be randomized in a 1:1 ratio to receive one of the following treatments for 8 weeks: * BDP/FF/G 100/6/12.5 mcg pMDI, two inhalations twice-daily * FluF/UMEC/VI 100/62.5/25 mcg DPI, one inhalation once-daily A subsequent visit will be performed at 8 weeks (V3), where participants will undergo spirometry, oscillometry, and imaging."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults ages 18 to 75 whose asthma is not well controlled. It uses lung imaging to study large and small airways and how two inhaled medicines, Trimbow and Trelegy Ellipta, reach the lungs.

The purpose of the study is to enroll participants with uncontrolled asthma to evaluate the large and small airways and drug delivery utilizing two study drugs: * Beclometasone dipropionate/Formoterol fumarate dihydrate/Glycopyrronium bromide (BDP/FF/G) or Trimbow * Fluticasone furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI ) or Trelegy Ellipta

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before any study tests.
  • Be 18 to 75 years old.
  • Have confirmed asthma, with a record of asthma for at least 1 year and diagnosis before age 40, and/or a breathing test result of 50% to 80% of the expected normal value after a break from airway-opening medicines.
  • Still have symptoms while using an inhaled steroid and a long-acting airway-opening medicine, with an Asthma Control Test score below 20.
  • Have had no asthma flare-up in the past 3 months that needed steroid pills or shots, an emergency room visit, or a hospital stay.
  • Be able to learn to use both a spray inhaler and a dry powder inhaler correctly.
  • Be able to follow study steps, do breathing tests while sitting and lying down, and understand the risks.
  • If able to become pregnant, you or your partner must use highly effective birth control from consent through follow-up, unless a doctor confirms your male partner cannot father a child. People who cannot become pregnant may also join.

Who can't join

  • Be pregnant or breastfeeding, or have a milk protein allergy.
  • Have had a flare-up in the past 3 months needing steroid pills or shots, antibiotics, or a hospital stay; or have used steroid pills or shots in the past 4 weeks or slow-release steroids in the past 12 weeks.
  • Be unable to do lung tests, follow study steps, take study medicines, or have CT or MRI scans; or be unable to tolerate xenon gas.
  • Have had nearly fatal asthma or an intensive care stay for asthma that the study doctor believes makes joining too risky.
  • Have COPD, a long-term lung disease that limits airflow, or another major lung disease, such as cystic fibrosis, damaged and widened airways, or a lack of the lung-protecting protein alpha-1 antitrypsin.
  • Currently smoke or vape, have quit smoking within the past year, or have smoked at least 10 pack-years in total—for example, 1 pack a day for 10 years.
  • Have a serious heart condition as judged by the study doctor, such as heart failure, recent problems with blood flow to the heart, or certain abnormal heart rhythms or electrical signals.
  • Have taken part in a study testing a treatment within the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Subject's written informed consent obtained prior to any study-related procedure. * Patients aged ≥ 18 and ≤ 75 years * Confirmed diagnosis of asthma (patients must have a documented history of asthma for at least 1 year with diagnosis before the age of 40 and/or pre-bronchodilator FEV1 between 50-80% of their predicted normal value, after appropriate washout from bronchodilators) * Symptomatic on ICS/LABA treatment with ACT \<20 * No exacerbations in the past 3 months requiring treatment with systemic corticosteroids or emergency department visit/ in-patient hospitalization * The ability to be trained and correctly use a pressurized Meter Dose Inhaler (pMDI) and Dry Powder Inhaler (DPI) * To have a cooperative attitude and the ability to perform the required outcomes measurements (e.g. spirometry maneuvers in sitting and supine position) and the ability to understand the risks involved * WOCBP fulfilling one of the following criteria: 1. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or 2. WOCBP with physician confirmed non-fertile male partners (contraception is not required in this case). * Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile, e.g. amenorrheic for ≥12 consecutive months without alternative medical cause). Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges). Exclusion Criteria: * Pregnant or lactating female * Patients who had an exacerbation, defined as a sustained and acute deterioration of subject's symptoms and signs (dyspnea, cough and/or sputum production/purulence) that was either moderate, i.e. require treatment with systemic (oral/IV/IM) corticosteroids and/or antibiotics, or severe, i.e. require hospitalization, if their associated treatment/hospitalization occurred within 3 months prior to V1 * Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake * History of near fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the Investigator, may have placed the patient at undue risk * Patients using systemic corticosteroid medication in the 4 weeks or slow-release corticosteroids in the 12 weeks, prior to screening * Patients who suffer from COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) document * History of a diagnosis of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may have interfered with study evaluations * Current smokers or current use of electronic cigarettes or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking one year or less prior to screening visit * Patients who had clinically significant cardiovascular condition according to investigator's judgement, such as but not limited to: congestive heart failure (NYHA class \>2), acute ischemic heart disease in the last year prior to study screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months (sustained meant lasting more than 30 seconds or ending only with external action, or led to hemodynamic collapse; non-sustained meant \>3 beats \<30 seconds, and or ending spontaneously, and or asymptomatic), high degree impulse conduction blocks (\>2nd degree atrioventricular block type 2). Similarly, patients affected by persistent, long standing or paroxysmal AF were not considered for enrollment * Patients who are unable to undergo imaging procedures for CT scans or MRI or demonstrate intolerance to Xenon gas * Patients who have participated in a recent therapeutic trial (within past 6 months) * Patients who have a milk protein allergy

Study sites (1)

AL