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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Beclometasone Dipropionate and Formoterol Inhalation Aerosol

    Drug

    Beclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks.

  • FOSTER®

    Drug

    Beclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks.

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: Beclometasone Dipropionate and Formoterol Inhalation AerosolExperimental treatment 1 intervention
Group B: FOSTER®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in forced expiratory volume in 1 second (FEV1) at Week 4

Absolute change in FEV1 (in liters) from baseline to Week 4, measured by spirometry.

Time frame
Baseline to Week 4.(at the end of the 4-week treatment period)

Secondary outcomes

1

Change from baseline in mean daily diurnal variability of peak expiratory flow (PEF)

Change from baseline in mean daily diurnal variability rate of peak expiratory flow (PEF) at the end of the 2-week and 4-week treatment periods.(Unit: %; Time points: Baseline to Week 2; Baseline to Week 4.

Time frame
Baseline to Week 2; Baseline to Week 4.
2

Change from baseline in trough (pre-dose) FEV1 at Week 2

Change from baseline in pre-dose forced expiratory volume in 1 second (FEV1) at Week 2, measured at the end of the 2-week treatment period prior to the next inhalation.Unit: L; Time Frame: Baseline to Week 2 (assessed immediately before the scheduled dose at the end of Week 2).

Time frame
Baseline to Week 2 (assessed immediately before the scheduled dose at the end of Week 2
3

Change from baseline in forced vital capacity (FVC) at Weeks 2 and 4 (end of treatment)

Liters (L)

Time frame
Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)
4

Change from baseline in FEV1/FVC ratio at Weeks 2 and 4 (end of treatment)

Percentage (%)

Time frame
Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lunan Better Pharmaceutical Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
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