Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)

NCT03888131 | Completed Phase 3 Results

• 2 other identifiers: CCD-01535AC1-02CTR20180475
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 53

Brief Summary

Primary Objective To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD. Secondary Objectives

• To evaluate the effect of CHF 1535 pMDI on other lung function parameters, and patient reported outcomes (PROs);
• To assess the safety and the tolerability of the study treatments.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Lung functions; COPD; Symbicort Turbohaler

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

  Forced Expiratory Volume in 1 second (FEV1) measures lung function by quantifying the volume of air forcefully exhaled during the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and Week 24 to assess treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, was used as the reference for changes post-treatment. Tests were performed under controlled conditions using calibrated equipment. Patients inhaled deeply to full capacity and exhaled forcefully into the spirometer. Each completed at least three acceptable maneuvers, with the highest value recorded for analysis. FEV1 higher values indicate better lung function. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction, making it a key parameter in COPD management.

  Baseline and week 24

Secondary Outcomes (8)

• Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits in Patients With Chronic Obstructive Pulmonary Disease (COPD)

  Baseline and week 4, week 12, week 18

• Change From Baseline in Pre-dose Morning Force Vital Capacity (FVC) at All Timepoints

  Baseline and week 4, week 12, week 18 and week 24

• Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Timepoints

  Baseline and week 4, week 12, week 18 and week 24

• Change From Baseline in Pre-dose Maximal Mid-expiratory Flow (MMEF) at All Timepoints

  Baseline and week 4, week 12, week 18 and week 24

• Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score and Domain Scores at Week 12 and Week 24

  Baseline, week 12, week 24

Study Arms (2)

CHF 1535 100/6 µg pMDI

EXPERIMENTAL

The experimental arm included 377 patients who received CHF 1535, a fixed-dose combination of beclometasone dipropionate (100 µg) and formoterol fumarate (6 µg). The treatment was administered as two inhalations twice daily (b.i.d.) via a pressurized metered-dose inhaler (pMDI), resulting in a total daily dose of 400 µg of beclometasone dipropionate and 24 µg of formoterol fumarate. During the initial 4-week run-in phase, patients in this group were treated with Symbicort® Turbohaler® 160/4.5 µg, administered as two inhalations b.i.d., to stabilize their clinical condition. After this period, patients transitioned to the randomized treatment phase, where they received CHF 1535 for 24 weeks. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d.

Drug: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo

Symbicort® Turbohaler®

ACTIVE COMPARATOR

The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d.

Drug: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo

Interventions

CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo DRUG

2 inhalations BID Total Daily Dose = 400/24µg

Also known as: Foster®, Beclometasone Dipropionate/Formoterol Fumarate (BDP/FF)

CHF 1535 100/6 µg pMDI

Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo DRUG

2 inhalations BID Total Daily Dose = 640/18µg

Also known as: Budesonide/Formoterol Fumarate (BUD/FF)

Symbicort® Turbohaler®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients had to meet all of the following criteria to be eligible for enrolment into the study:
• Male and female adults aged ≥40 years, of Chinese ethnicity with written informed consent prior to any study-related procedure;
• Patients with a diagnosis of COPD (according to the GOLD document \[1\], updated 2017) at least 12 months before the screening visit;
• 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;
• 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;
• 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";
• 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;
• A cooperative attitude and ability to be trained to use correctly the study treatment inhalers (pMDI and Turbohaler®);
• A cooperative attitude and ability to be trained to use correctly the COPD questionnaires.

You may not qualify if:

• 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;
• COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period;
• 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;
• 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;
• 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);
• 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);
• Patients requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
• History of hypersensitivity to β2-agonists, corticosteroids or any of the excipients contained in any of the formulations used in the study;
• Patients treated with non-cardioselective β-blockers in the 4 weeks preceding the screening visit or during the run-in period;
• 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);
• Patients with atrial fibrillation:

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (53)

Site 15604 - Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Site 15635 - The Second Hospital of Anhui Medical Hospital

Hefei, Anhui, 231200, China

Location

Site 15613 - Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Site 15611 - Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Site 15640 - Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location

Site 15626 - Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Site 15612 - Beijing Tong Ren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Site 15634 - Chongqing General Hospital

Chongqing, Chongqing Municipality, 400013, China

Location

Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District

Chongqing, Chongqing Municipality, 400020, China

Location

Site 15636 - Fujian Province Hospital

Fuzhou, Fujian, 350001, China

Location

Site 15650 - The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Site 15630 - Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

Location

Site 15607 - The First People's Hospital of Shunde

Foshan, Guangdong, 528300, China

Location

Site 15619 - The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Site 15608 - The First Affiliated Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510030, China

Location

Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Site 15651 - The Second Xiangya Hospital of Central South University

Guangzhou, Guangdong, 510260, China

Location

Site 15614 - Guangzhou Panyu central hospital

Guangzhou, Guangdong, 511400, China

Location

Site 15618 - Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524000, China

Location

Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi Zhuang, 530021, China

Location

Site 15637 - Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, 563099, China

Location

Site 15623 - Haikou People's Hospital

Haikou, Hainan, 570208, China

Location

Site 15645 - Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Site 15654 - Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Site 15617 - Henan Provincial Chest Hospital

Zhengzhou, Henan, 450008, China

Location

Site 15622 - The Third Hospital of Changsha

Changsha, Hu'nan, 410015, China

Location

Site 15647 - The Second hospital. University of South China

Hengyang, Hu'nan, 421001, China

Location

Site 15653 - Xiangtan Central Hospital

Xiangtan, Hu'nan, 411100, China

Location

Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China

Location

Site 15657 - Zhong Da Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Site 15627 - Nanjing Medical University Affiliated 2nd Hospital

Nanjing, Jiangsu, 210011, China

Location

Site 15621 - Wuxi People's Hospital

Wuxi, Jiangsu, 241023, China

Location

Site 15632 - Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Site 15659 - Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

Location

Site 15658 - Jilin Province People's Hospital

Changchun, Jilin, 130021, China

Location

Site 15643 - No.2 Hospital Affiliated to Jilin University

Changchun, Jilin, 130041, China

Location

Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, 116033, China

Location

Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University

Taiyuan, Shan'xi, 030001, China

Location

Site 15644 - Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Site 15629 - Shanghai East Hospital

Shanghai, Shanghai Municipality, 2000120, China

Location

Site 15628 - Shanghai Xuhui Center Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Site 15601 - Huadong Hospital Afflilliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Site 15631 - Shanghai Yangpu District Centre Hospital

Shanghai, Shanghai Municipality, 200090, China

Location

Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200336, China

Location

Site 15606 - Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Site 15625 - Central Hospital of Shanghai Minhang District

Shanghai, Shanghai Municipality, 201199, China

Location

Site 15638 - Second Hospital of Shanxi Medical

Taiyuan, Shanxi, 0300001, China

Location

Site 15605 - West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Site 15609 - Tianjin First Center Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

Site 15633 - Tianjin Haihe Hospital

Tianjin, Tianjin Municipality, 300350, China

Location

Site 15602 - Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

Site 15642 - Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

Location

Site 15639 -The second Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (1)

• Wen F, Wu Y, Xing C, Zhu Y, Chen Y, Mei X, Corradi M, Cappellini G, Calabro E, Amodio S, Zhu C, Galkin D. Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study. COPD. 2024 Dec;21(1):2425157. doi: 10.1080/15412555.2024.2425157. Epub 2024 Nov 11.

  PMID: 39529298 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Foster Home Care; Beclomethasone; Formoterol Fumarate; Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes

Results Point of Contact

• Title: Clinical Trial INFO
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+39 0521 2791

Study Officials

• Professor Fuqiang WEN, M.D., Ph.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: March 25, 2019
• Study Start: July 30, 2018
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (53)