Phase 3
N=750
Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT03888131 ↗Enrolled (actual)
750
Serious AEs
12.3%
Results posted
May 2026
Primary outcome: Primary: Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD) — -0.020; -0.019 liters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo (Drug); Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
-0.020; -0.019 | <0.001 sig |
| SECONDARY Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
-0.005; -0.006; -0.014; -0.015; -0.007; -0.014 | 0.887 |
| SECONDARY Change From Baseline in Pre-dose Morning Force Vital Capacity (FVC) at All Timepoints |
0.001; -0.024; -0.013; -0.057; 0.012; -0.017 | 0.297 |
| SECONDARY Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Timepoints |
-0.004; 0.012; -0.009; 0.011; -0.015; 0.019 | 0.471 |
| SECONDARY Change From Baseline in Pre-dose Maximal Mid-expiratory Flow (MMEF) at All Timepoints |
-0.004; -0.004; -0.007; 0.002; -0.006; -0.007 | 0.989 |
| SECONDARY Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score and Domain Scores at Week 12 and Week 24 |
-1.62; -1.39; -1.62; -1.68; -2.82; -2.01 | 0.785 |
| SECONDARY Change From Baseline in COPD Assessment Test (CAT) |
0.0; -0.2; -0.1; 0.0; 0.2; 0.0 | 0.514 |
| SECONDARY Rate of Moderate and Severe COPD Exacerbations Over 24 Weeks of Treatment. - Moderate Exacerbations Require Treatment With Systemic Corticosteroids and/or Antibiotics - Severe Exacerbations Require Hospitalisation or Result in Death |
0.474; 0.547 | 0.372 |
| SECONDARY Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
195; 191; 45; 47; 15; 17 | — |
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.
Eligibility Criteria
Inclusion Criteria
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 450 ms for males or QTcF >470 ms for females;
- 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;
- 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;
- Patients with serum potassium levels <3.5 mEq/L (or 3.5 mmol/L);
- History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit;
- 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;
- 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).
Data sourced from ClinicalTrials.gov (NCT03888131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.