Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
Recruiting · NCT07301736 · Interventional (participants receive a specific treatment) · Lead sponsor: Chiesi Farmaceutici S.p.A.
View the official record on ClinicalTrials.gov →Interventions studied
CHF5993 pMDI with HFA-134aCHF5993 pMDI with HFA-152aCHF718 pMDI with HFA-134a
What this trial is about
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;
- Non-smokers, ex-smokers;
- Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive;
- Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:
- low or medium doses of ICS (Inhaled Corticosteroids) alone; or
- low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).
- Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score \<1.5 at screening and at randomisation.
- Pre-BD (Bronchodilator) FEV1 \>40% and \<90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).
- A demonstrated increase in either FEV1 or forced vital capacity of \>12% and \>200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).
Exclusion criteria
- History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;
- Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ;
- Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
- Asthma subjects currently treated with any of the following :
- High dose ICS;
- Long-acting muscarinic antagonist (LAMA);
- Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
- Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
- Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;
- Respiratory disorders other than asthma
- Lung resection;
- Lower respiratory tract infection;
- Lung cancer and history of lung cancer;
- Subjects with active cancer or a history of cancer (other than lungs) ;
- Patients who have clinically significant cardiovascular condition;
- Run-in compliance: e-Diary completion \<75% and run-in treatment compliance \<75% at randomisation;
Where it is running
60 locations listed.
- Velocity Clinical Research Germany, Ahrensburg_Site n. 276020 - Ahrensburg, Germany
- Spitalul de Pneumoftiziologie Bacau_Site n. 642014 - Bacau, Romania
- University Clinical Centre of the Republic of Srpska - Paprikovac_Site n. 070004 - Banja Luka, Bosnia and Herzegovina
- Alian, s.r.o._Site n. 703001 - Bardejov, Slovakia
- Ormeau Clinical Trials Ltd._Site n. 826005 - Belfast, United Kingdom
- KBC "Dr Dragiša Mišović-Dedinje"_Site n. 688004 - Belgrade, Serbia
- Klinicki Centar Srbije (KCS) - Klinika za Pulmologiju_Site n. 688009 - Belgrade, Serbia
- Municipal Institute for Lung Disease and Tuberculosis_Site n. 688010 - Belgrade, Serbia
- Tiervlei Trial Centre_Site n. 710007 - Bellville, South Africa
- Worthwhile Clinical Trials_Site n. 710003 - Benoni, South Africa
- Studienpraxis Berlin-Brandenburg_Site n. 276005 - Berlin, Germany
- Praxis an der Oper_Site n. 276016 - Berlin, Germany
- Lungenpraxis Hohenzollerndamm_Site n. 276004 - Berlin, Germany
- Velocity Clinical Research Germany GmbH_Site 276010 - Berlin, Germany
- Polikum Institut GmbH_Site n. 276006 - Berlin, Germany
- Institute for Allergy and Asthma Research Berlin, IAAB_Site n. 276008 - Berlin, Germany
- MECS research GmbH_Site 276011 - Berlin, Germany
- IATROS International_Site n. 710008 - Bloemfontein, South Africa
- ANGISAN GRUP SRL_Site n. 642005 - Bragadiru, Romania
- Pneumo Bronho Med_Site n. 642002 - Brasov, Romania
- Theramed Healthcare S.R.L._Site n. 642001 - Brasov, Romania
- North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010 - Bristol, United Kingdom
- Concord Medical Centre_Site n. 826009 - Bristol, United Kingdom
- Spitalul Clinic Colentina_Site n. 642010 - Bucharest, Romania
- Spitalul Clinic Nr.1 Cai Ferate Witing_Site n. 642008 - Bucharest, Romania
- Delta Health Care S.R.L._Site n. 642006 - Bucharest, Romania
- Hospital Británico de Buenos Aires_Site n. 032029 - Buenos Aires, Argentina
- Centro Medico de Enfermedades Respiratorias_Site n. 032002 - Buenos Aires, Argentina
- Centro Medico Respire_Site n. 032014 - Buenos Aires, Argentina
- Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018 - Buenos Aires, Argentina
- Centro de Investigaciones Médicas Mar del Plata_Site n. 032019 - Buenos Aires, Argentina
- Fundacion CIDEA_Site n. 032009 - Buenos Aires, Argentina
- Centro Medico Arsema_Site n. 032003 - Buenos Aires, Argentina
- Trial Pharma Kft. - TPKFT_Site n. 348011 - Békéscsaba, Hungary
- Task Applied Science (TASK) - Central Location_Site n. 710015 - Cape Town, South Africa
- Precise Clinical Solutions_Site n. 710004 - Chatsworth, South Africa
- Chernivtsi Regional Clinical Hospital_Site n. 804006 - Chernivtsi, Ukraine
- Centro de Investigaciones Metabólicas (CINME)_Site n. 032025 - Ciudad Autonoma de Buenos Aire, Argentina
- Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015 - Ciudad Autonoma de Buenos Aire, Argentina
- CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028 - Ciudad Autonoma de Buenos Aire, Argentina
- Consultorio Medico Dra. Rivera_Site n. 032012 - Ciudad Autonoma de Buenos Aire, Argentina
- Fundación Respirar Salud_Site n. 032004 - Ciudad Autonoma de Buenos Aire, Argentina
- MECS Cottbus GmbH_Site n. 276007 - Cottbus, Germany
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Dr. Victor Babeș" Craiova_Site n. 642003 - Craiova, Romania
- Instituto de Medicina Respiratoria (IMER) - Cordoba_Site n. 032023 - Córdoba, Argentina
- Elpida Trials - Parloes Hub_Site n. 826003 - Dagenham, United Kingdom
- Klifeck GmbH_Site n. 276002 - Delitzsch, Germany
- SC Medical Center SRL_Site n. 642013 - Deva, Romania
- Clinical Hospital of Emergency Medical Care of the Dnipro City Council Allergy Center_Site n. 804014 - Dnipro, Ukraine
- Sveti apostol Luka Doboj_Site n. 070005 - Doboj, Bosnia and Herzegovina
- CIAID - Centro de Investigacion y Atencion Integral Durango, S.C._Site n. 484006 - Durango, Mexico
- Synapta Clinical Research Centre_Site n. 710006 - Durban, South Africa
- Schwerpunktpraxis Lungen- und Bronchialheilkunde Allergologie und Schlafmedizin_Site n. 276009 - Düsseldorf, Germany
- Edelenyi Koch Robert Korhaz Es Rendelointezet_Site n. 348013 - Edelény, Hungary
- TASK Eden_Site n. 710001 - George, South Africa
- MHAT Sv. Ivan Rilski - Gorna Oryahovitsa_Site n.100017 - Gorna Oryahovitsa, Bulgaria
- Szalay Janos Rendelointezet_Site n. 348006 - Hajdúnánás, Hungary
- Velocity Clinical Research Germany GmbH_Site n. 276019 - Hamburg, Germany
- Medical Center Pulmo - 2018_Site n. 100007 - Haskovo, Bulgaria
- BKS Research Kft._Site n. 348001 - Hatvan, Hungary
Showing 60 of 167 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →