Beclometasone Dipropionate and Formoterol Inhalation Aerosol for Asthma
ConditionAsthma (Diagnosis)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLunan Better Pharmaceutical Co., LTD.
About this trial
A multicenter, randomized, double-blind, active-controlled, parallel-group Phase III clinical study comparing the efficacy and safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol versus FOSTER® in patients with asthma. The purpose of this study is to compare the efficacy and safety of the Beclomethasone Dipropionate and Formoterol Fumarate inhalation aerosol (manufactured by Lunan Better Pharmaceutical Co., Ltd.) with FOSTER® in the treatment of patients with asthma.
Eligibility criteria
Qualifiers
Male or female aged ≥18 and ≤75 years.
Within at least 4 weeks prior to signing the ICF, the subject has been on a stable daily dose of an inhaled corticosteroid (ICS) with "as-needed" short-acting β₂-agonist (SABA) use but asthma is not well controlled (ACQ-5 ≥1.00), OR has been on a stable daily dose of an ICS plus a long-acting β₂-agonist (LABA) and asthma is well controlled (ACQ-5 <1.00).
Subjects who use SABA or other reliever medications as needed before screening may be enrolled only if the investigator assesses that they can be switched to the unified rescue medication provided in this study.
Willing and able to comply with the protocol requirements and the investigator's instructions for pulmonary function tests, and, after training, able to correctly use the pressurized metered-dose inhaler (pMDI), peak flow meter, and complete the diary card records.
Disqualifiers
Have intermittent asthma or asthma that occurs only upon occasional exposure to allergens or chemical sensitizers.
Have a history of life-threatening asthma (e.g., brittle asthma, admission to the intensive care unit due to an acute asthma exacerbation) within 1 year prior to screening.
Have other respiratory system diseases, including but not limited to allergic bronchopulmonary aspergillosis (ABPA), active tuberculosis, pneumonia, pneumothorax, idiopathic pulmonary fibrosis, clinically significant atelectasis, chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia, chronic bronchitis, or other significant pulmonary abnormalities other than asthma (such as cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency), and are considered by the investigator to be unsuitable for participation in this clinical study.
Have a respiratory tract infection of non-viral etiology, sinusitis, or otitis media within 4 weeks prior to screening.
Trial design
Treatments tested in this trial
- Beclometasone Dipropionate and Formoterol Inhalation Aerosol
- FOSTER®
Treatment groups
416 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov