New triple inhaler shows promise for better breathing in COPD

NCT ID NCT03197818

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

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This phase 3 trial tested whether a triple-combination inhaler (CHF 5993) works better than a standard dual inhaler (Symbicort) for people with chronic obstructive pulmonary disease (COPD). Over 700 adults aged 40 and older with a history of smoking took part. The main goal was to see if the triple inhaler improved lung function more than the dual inhaler after 24 weeks.

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 / formoterol fumarate / glycopyrronium bromide (triple-combination inhaler)
What this could lead to: If successful, this triple inhaler could offer better lung function for people with COPD compared to a standard dual inhaler.
What could go wrong: This is a completed phase 3 trial, but results may not apply to all COPD patients. The improvement over the existing treatment may be small and not clinically meaningful for everyone.

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

708 people

The number who actually took part.

Started

Dec 2016

Finished

May 2020

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 inclusion criteria to be eligible for enrolment into the study: 1. Male and female adults aged ≥ 40 years with written informed consent obtained prior to any study-related procedure; 2. Patients with a diagnosis of COPD (according to GOLD 2015 strategic document, updated January 2015) 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 at least 10-15 mins after 4 puffs (4 x 100 μg) of salbutamol pMDI; 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 under therapy 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. 7. A cooperative attitude and ability to be trained to use correctly the study treatment inhalers (pMDI and Turbuhaler®); 8. A cooperative attitude and ability to be trained to use correctly the COPD questionnaires. All inclusion criteria were checked at screening (V1, Week -2). If criterion #4 was not met at V1, the test could be repeated once before the randomisation visit (V2, Week 0). Inclusion criteria #7 and #8 were to be re-checked at the randomisation visit (V2, Week 0). Exclusion Criteria: If a patient met any of the following criteria, he/she was not enrolled into the study: 1. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more of the following reliable methods of contraception: * Placement of an intrauterine device or intrauterine system; * Hormonal contraception (implantable, patch, oral); * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository; * Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). Reliable contraception had to be maintained throughout the study until last study visit. "True abstinence" was acceptable only if it was in line with the preferred and usual lifestyle of the patient. Pregnancy testing was carried out during the course of the study in all women of childbearing potential: serum pregnancy test was performed at screening (V1) and end of treatment (V6); and urine pregnancy test was performed at all visits except V0 and V6. Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhea") or women permanently sterilised (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) could have been enrolled in the study; 2. Diagnosis of asthma, history of allergic rhinitis or atopy (atopy which may raise contra-indications or impact the efficacy of the study according to Investigator's judgement); 3. 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 E (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; 4. COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalisation during the run-in period; 5. Changes in dose, schedule, formulation or product of oral xanthine derivatives (e.g. theophylline) in the month prior to screening visit or during the run-in period. Stop of xanthines prior to screening visit was allowed; 6. Patients treated with non-cardioselective β-blockers in the week preceding the screening visit or during the run-in period; 7. Patients treated with long-acting antihistamines (e.g. astemizole, terfenadine) unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as required (PRN); 8. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxaemia; 9. Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according to the Investigator's judgement. This can include but is not limited to alfa-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease; 10. Patients who had a clinically significant (CS) cardiovascular condition (such as but not limited to unstable ischaemic 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 (AF): * Paroxysmal (i.e. intermittent); * Persistent as defined by continuous AF 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 results in an active medical problem which may impact the safety of the patient according to Investigator's judgement. Patients whose ECG (12 lead) showed Fridericia-corrected QT interval (QTcF) \> 450 ms for males or QTcF \> 470 ms for females at screening and at randomisation visits were not eligible. 13. Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would prevent use of anticholinergic agents; 14. History of hypersensitivity to M3 antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial; 15. Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study treatment according to Investigator's judgement; 16. Patients with serum potassium levels \< 3.5 mEq/L (or 3.5 mmol/L) at screening; 17. 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, or other which may impact the feasibility of the results of the study according to Investigator's judgement; 18. History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit; 19. Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening visit; 20. Patients treated with Traditional Chinese Medicines used for respiratory diseases. All exclusion criteria except for criterion #4 were checked at screening (V1, Week -2). The following exclusion criteria were to be re-checked at the randomisation visit (V2, Week 0): #1, #4, #5, #6, #7, #10, #11, #12, #17, and #20. For patients in South Korea (only), the following were added to the South Korea-specific protocol (version 3.0): * For exclusion criterion #14, it was additionally specified that patients with a history of lactose intolerance were to be excluded; * For exclusion criterion #17, it was additionally specified that patients with a known history of hypersensitivity to sympathomimetic amine were to be excluded; * An additional exclusion criterion (#21) was specified for patients with a known history of hypertrophic cardiomyopathy.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

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

COPD (chronic obstructive pulmonary disease)

Contacts and locations

Locations

Chiesi Clinical Trial Site 156001

Guangzhou, 510230, China
Chiesi Clinical Trial Site 156002

Fuzhou, Fujian, 350005, China
Chiesi Clinical Trial Site 156004

Huai'an, Jiangsu, 223300, China
Chiesi Clinical Trial Site 156005

Shanghai, Shanghai Municipality, 200072, China
Chiesi Clinical Trial Site 156006

Shanghai, Shanghai Municipality, 200433, China
Chiesi Clinical Trial Site 156007

Shenyang, Liaoning, 110004, China
Chiesi Clinical Trial Site 156008

Zhanjiang, Guangdong, 524000, China
Chiesi Clinical Trial Site 156010

Chengdu, Sichuan, 610041, China
Chiesi Clinical Trial Site 156011

Shanghai, Shanghai Municipality, 200433, China
Chiesi Clinical Trial Site 156012

Beijing, Beijing Municipality, 100144, China
Chiesi Clinical Trial Site 156013

Guangzhou, Guangdong, 510080, China
Chiesi Clinical Trial Site 156014

Shanghai, Shanghai Municipality, 200025, China
Chiesi Clinical Trial Site 156015

Baotou, Inner Mongolia, 014010, China
Chiesi Clinical Trial Site 156026

Beijing, Beijing Municipality, 100020, China
Chiesi Clinical Trial Site 156036

Changchun, Jilin, 130000, China
Chiesi Clinical Trial Site 156038

Shanghai, Shanghai Municipality, 210009, China
Chiesi Clinical Trial Site 156039

Taiyuan, Shanxi, 030001, China
Chiesi Clinical Trial Site 156040

Changsha, Hunan, 410000, China
Chiesi Clinical Trial Site 156041

Nanchang, Jiangxi, 330000, China
Chiesi Clinical Trial Site 156042

Pingxiang, Jiangxi, 337000, China
Chiesi Clinical Trial Site 156043

Baotou, Inner Mongolia, 014000, China
Chiesi Clinical Trial Site 156044

Shijiangzhuang, Hebei, 050000, China
Chiesi Clinical Trial Site 156045

Chongqing, Chongqing Municipality, 400000, China
Chiesi Clinical Trial Site 156046

Linhai, Zhejiang, 317000, China
Chiesi Clinical Trial Site 156047

Jiujiang, Jiangxi, 332000, China
Chiesi Clinical Trial Site 156048

Guangzhou, Guangdong, 510000, China
Chiesi Clinical Trial Site 158001

Keelung, Keelung Municipality, 204, Taiwan
Chiesi Clinical Trial Site 158003

Douliu, Yunlin, 64041, Taiwan
Chiesi Clinical Trial Site 158004

Kaohsiung City, Penghu, 83301, Taiwan
Chiesi Clinical Trial Site 158005

Taipei, 11217, Taiwan
Chiesi Clinical Trial Site 158006

Kaohsiung City, 824, Taiwan
Chiesi Clinical Trial Site 158008

Taichung, Taiwan
Chiesi Clinical Trial Site 158010

Changhua, 500, Taiwan
Chiesi Clinical Trial Site 158011

Taipei, 220, Taiwan
Chiesi Clinical Trial Site 410001

Bucheon-si, Gyeonggido, 420-717, South Korea
Chiesi Clinical Trial Site 410002

Goyang-si, Gyeonggido, 10380, South Korea
Chiesi Clinical Trial Site 410003

Chuncheon, Gang'weondo, 24289, South Korea
Chiesi Clinical Trial Site 410004

Seoul, Seoul Teugbyeolsi, 100-032, South Korea
Chiesi Clinical Trial Site 410005

Jeonju, Jeonrabugdo, 54907, South Korea
Chiesi Clinical Trial Site 410006

Seoul, Seoul Teugbyeolsi, 136-705, South Korea
Chiesi Clinical Trial Site 410007

Seoul, Seoul Teugbyeolsi, 07985, South Korea
Chiesi Clinical Trial Site 410008

Seoul, Seoul Teugbyeolsi, 07345, South Korea
Chiesi Clinical Trial Site 410009

Gyeonggi-do, Seoul Teugbyeols, 135-720, South Korea
Chiesi Clinical Trial Site 410010

Daegu, Ulsan, 705-703, South Korea
Chiesi Clinical Trial Site 410011

Seoul, 04401, South Korea
Chiesi Clinical Trial Site 410012

Bucheon-si, Gyeonggido, 14584, South Korea
Chiesi Clinical Trial Site 410013

Seoul, 2559, South Korea
Chiesi Clinical Trial Site 410014

Seoul, 5030, South Korea
Chiesi Clinical Trial site 156003

Nanning, Guangxi, 530021, China
Chiesi clinical Trial Site 156017

Beijing, Beijing Municipality, 100029, China
Chiesi clinical Trial Site 156018

Hangzhou, Zhejiang, 310014, China
Chiesi clinical Trial Site 156019

Changchun, Jilin, 130021, China
Chiesi clinical Trial Site 156020

Haikou, Hainan, 570100, China
Chiesi clinical Trial Site 156022

Nanjing, Jiangsu, 210006, China
Chiesi clinical Trial Site 156023

Changchun, Jilin, 130000, China
Chiesi clinical Trial Site 156024

Foshan, Guangdong, 528000, China
Chiesi clinical Trial Site 156025

Yinchuan, Ningxia, 750000, China
Chiesi clinical Trial Site 156028

Nanchang, Jiangxi, 330006, China
Chiesi clinical Trial Site 156031

Beijing, Beijing Municipality, 100000, China
Chiesi clinical Trial Site 156032

Chongqing, Sichuan, 400000, China
Chiesi clinical Trial Site 156033

Jiangyin, Jiangsu, 320281, China
Chiesi clinical Trial Site 156034

Tianjin, Tianjin Municipality, 300052, China
Chiesi clinical Trial Site 156035

Chengdu, Sichuan, 610000, China
Chiesi clinical Trial Site 156037

Shanghai, Shanghai Municipality, 200031, China

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