New COPD inhaler matches standard treatment in lung function trial

NCT ID NCT03888131

Disease control Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether a new inhaler (beclometasone/formoterol) works as well as an existing one (budesonide/formoterol, Symbicort) for people with chronic obstructive pulmonary disease (COPD). Over 24 weeks, 750 Chinese adults with moderate-to-severe COPD used one of the two inhalers twice daily. The main goal was to measure changes in lung function (FEV1) from the start to the end of the study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Beclometasone dipropionate plus formoterol fumarate (inhaler)
What this could lead to: If this inhaler works as well as the current standard, it could offer another effective option for managing COPD symptoms and improving lung function.
What could go wrong: This is a non-inferiority trial, meaning it only aims to show the new inhaler is not worse than the existing one, not that it is better. Results may not apply to non-Chinese populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

750 people

The number who actually took part.

Started

Jul 2018

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients had to meet all of the following criteria to be eligible for enrolment into the study: 1. Male and female adults aged ≥40 years, of Chinese ethnicity with written informed consent prior to any study-related procedure; 2. Patients with a diagnosis of COPD (according to the GOLD document \[1\], updated 2017) at least 12 months before the screening visit; 3. A smoking history of at least 10 pack-years \[pack-years = (number of cigarettes per day x number of years)/20\]. Current and ex-smokers were eligible; Note: Smoking cessation therapy had to be completed 6 months prior to screening visit; 4. A post-bronchodilator FEV1 \<50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \<0.7, 10 to 15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI; Note: If this criterion was not met at screening, the test could be repeated no more than 7 days before the randomisation visit; 5. A documented history of at least one exacerbation in the 12 months preceding the screening visit. COPD exacerbation was defined according to the following: "A sustained worsening of the patient's condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics or need for hospitalisation"; 6. Patients in treatment for at least 2 months prior to screening with either: * ICS/LABA; or * ICS/LAMA; or * Inhaled LABA and inhaled LAMA; or * LAMA; or * LABA; Note: Triple therapy was not allowed 2 months before the screening visit; 7. A cooperative attitude and ability to be trained to use correctly the study treatment inhalers (pMDI and Turbohaler®); 8. A cooperative attitude and ability to be trained to use correctly the COPD questionnaires. Exclusion Criteria: 1. Patients requiring use of the following medications: * Systemic steroids for COPD exacerbation in the 4 weeks prior to screening; * A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening; * Phosphodiesterase (PDE) inhibitors in the 4 weeks prior to screening; * Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) in the 4 weeks prior to screening; 2. COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period; 3. Changes in dose, schedule, formulation or product of oral xanthine derivatives (e.g. theophylline) in the month prior to the screening visit or during the run-in period. Stop of xanthines prior to the screening visit was allowed; 4. Known respiratory disorders other than COPD which may have impacted the efficacy of the study treatment according to the Investigator's judgement. This could have included, but was not limited to, α-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease; 5. Diagnosis of asthma, history of allergic rhinitis or atopy (atopy which may have risen contra-indications or impacted the efficacy of the study according to the Investigator's judgement); 6. Patients treated with long-acting antihistamines (e.g. astemizole, terfenadine) unless taken at stable regimen at least 2 months prior to screening and maintained constant during the study, or if taken as required (PRN); 7. Patients requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia; 8. History of hypersensitivity to β2-agonists, corticosteroids or any of the excipients contained in any of the formulations used in the study; 9. Patients treated with non-cardioselective β-blockers in the 4 weeks preceding the screening visit or during the run-in period; 10. Patients who had a clinically significant (CS) active cardiovascular condition (such as, but not limited to, unstable ischemic heart disease, New York Heart Association \[NYHA\] Class III/IV, left ventricular failure, acute myocardial infarction, advanced atrio-ventricular conduction blocks); 11. Patients with atrial fibrillation: * Paroxysmal (i.e. intermittent); * Persistent as defined by continuous atrial fibrillation diagnosed for less than 6 months; * Persistent for at least 6 months with a resting ventricular rate ≥100/minute controlled with a rate control strategy (i.e. selective β-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy); 12. An abnormal and CS 12-lead ECG that resulted in an active medical problem which may have impacted the safety of the patient or showed Fridericia-corrected QT interval (QTcF) \>450 ms for males or QTcF \>470 ms for females; 13. Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, significant hepatic impairment, significant renal impairment or other which may impact the feasibility of the results of the study according to the Investigator's judgment; 14. CS laboratory abnormalities indicating a significant or unstable concomitant disease which may have impacted the efficacy or the safety of the study treatment according to the Investigator's judgment; 15. Patients with serum potassium levels \<3.5 mEq/L (or 3.5 mmol/L); 16. History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit; 17. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they were using one or more of the following highly effective contraceptive measures: * Placement of an intrauterine device or intrauterine hormone-releasing system; * Combined (oestrogen and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); * Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); * Bilateral tubal occlusion; * Vasectomised partner; Reliable contraception had to be maintained throughout the study; Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhea without an alternative medical cause") or women permanently sterilised (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy) could be enrolled in the study; Pregnancy tests were performed at study entry (a serum test at the screening visit and a urine test at screening and randomisation visits) in all women of childbearing potential; 18. Participation in an interventional clinical trial with intake of the last dose of any investigational drug \<12 weeks preceding baseline visit (last dose \<5 half-lives prior to baseline visit for biologics).

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

Contacts and locations

Locations

Site 15601 - Huadong Hospital Afflilliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China
Site 15602 - Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China
Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China
Site 15604 - Anhui Provincial Hospital

Hefei, Anhui, 230001, China
Site 15605 - West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China
Site 15606 - Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China
Site 15607 - The First People's Hospital of Shunde

Foshan, Guangdong, 528300, China
Site 15608 - The First Affiliated Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510030, China
Site 15609 - Tianjin First Center Hospital

Tianjin, Tianjin Municipality, 300192, China
Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200336, China
Site 15611 - Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China
Site 15612 - Beijing Tong Ren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China
Site 15613 - Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China
Site 15614 - Guangzhou Panyu central hospital

Guangzhou, Guangdong, 511400, China
Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District

Chongqing, Chongqing Municipality, 400020, China
Site 15617 - Henan Provincial Chest Hospital

Zhengzhou, Henan, 450008, China
Site 15618 - Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524000, China
Site 15619 - The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China
Site 15621 - Wuxi People's Hospital

Wuxi, Jiangsu, 241023, China
Site 15622 - The Third Hospital of Changsha

Changsha, Hu'nan, 410015, China
Site 15623 - Haikou People's Hospital

Haikou, Hainan, 570208, China
Site 15625 - Central Hospital of Shanghai Minhang District

Shanghai, Shanghai Municipality, 201199, China
Site 15626 - Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China
Site 15627 - Nanjing Medical University Affiliated 2nd Hospital

Nanjing, Jiangsu, 210011, China
Site 15628 - Shanghai Xuhui Center Hospital

Shanghai, Shanghai Municipality, 200031, China
Site 15629 - Shanghai East Hospital

Shanghai, Shanghai Municipality, 2000120, China
Site 15630 - Dongguan People's Hospital

Dongguan, Guangdong, 523059, China
Site 15631 - Shanghai Yangpu District Centre Hospital

Shanghai, Shanghai Municipality, 200090, China
Site 15632 - Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China
Site 15633 - Tianjin Haihe Hospital

Tianjin, Tianjin Municipality, 300350, China
Site 15634 - Chongqing General Hospital

Chongqing, Chongqing Municipality, 400013, China
Site 15635 - The Second Hospital of Anhui Medical Hospital

Hefei, Anhui, 231200, China
Site 15636 - Fujian Province Hospital

Fuzhou, Fujian, 350001, China
Site 15637 - Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, 563099, China
Site 15638 - Second Hospital of Shanxi Medical

Taiyuan, Shanxi, 0300001, China
Site 15639 -The second Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China
Site 15640 - Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China
Site 15642 - Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China
Site 15643 - No.2 Hospital Affiliated to Jilin University

Changchun, Jilin, 130041, China
Site 15644 - Jinan Central Hospital

Jinan, Shandong, 250013, China
Site 15645 - Hainan General Hospital

Haikou, Hainan, 570311, China
Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China
Site 15647 - The Second hospital. University of South China

Hengyang, Hu'nan, 421001, China
Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, 116033, China
Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University

Taiyuan, Shan'xi, 030001, China
Site 15650 - The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China
Site 15651 - The Second Xiangya Hospital of Central South University

Guangzhou, Guangdong, 510260, China
Site 15653 - Xiangtan Central Hospital

Xiangtan, Hu'nan, 411100, China
Site 15654 - Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China
Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi Zhuang, 530021, China
Site 15657 - Zhong Da Hospital, Southeast University

Nanjing, Jiangsu, 210009, China
Site 15658 - Jilin Province People's Hospital

Changchun, Jilin, 130021, China
Site 15659 - Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

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