Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.

NCT03453112 | Completed Phase 3 Results

• 2 other identifiers: CCD-01535BA0-01CTR20170917
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 51

Brief Summary

Primary Objective To demonstrate the non-inferiority of Foster® NEXThaler® 100/6 µg versus (vs.) Foster® pressurised metered dose inhaler (pMDI) 100/6 µg in terms of pulmonary function (change from baseline to the entire treatment period in average pre-dose morning peak expiratory flow \[PEF\]) in asthmatic patients. Secondary Objectives To evaluate the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures, and to assess the safety and tolerability.

Conditions

Asthma

Keywords

Peek Expiratory Flow (PEF) Lung function tests; Foster® NEXThaler®; Foster® pMDI

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Treatment Period in Average Pre-dose Morning Peak Expiratory Flow (PEF)

  PEF= peak expiratory flow. The peak expiratory flow (also known as a peak flow or peak flow rate) is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. In this study PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3). * The average pre-dose morning PEF over the entire treatment period was computed as: ∑Valid pre-dose morning Best PEF values (treatment period) / Number of days with available data * Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min

  Baseline (Week 0, Visit 3) and Week 12 (EoT)

Secondary Outcomes (13)

• Change From Baseline to Each 2-week (Inter-visit) Treatment Period in Average Pre-dose Morning Peek Expiratory Flow (PEF)

  Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)

• Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Pre-dose Evening PEF

  Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.

• Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Daily PEF Variability

  Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

• Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Use of Rescue Medication (Number of Puffs/Day)

  Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

• Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Rescue Medication-Free Days

  Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Study Arms (2)

Foster 100/6µg NEXThaler

EXPERIMENTAL

Patients in this arm received Foster® NEXThaler® 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI). Treatment Details: * Dosage: 2 inhalations twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily. * Duration: 12 weeks. * Administration: First dose under medical supervision at randomization (Week 0). Blinding \& Control Treatment: * A double-dummy design was used. Patients also received a placebo pMDI (matching active pMDI), administered as 2 puffs b.i.d. to maintain blinding. Background Therapy: * Salbutamol was provided as rescue medication. Patient Training \& Compliance: * Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.

Drug: Foster 100/6µg NEXThaler

Foster 100/6µg pMDI

ACTIVE COMPARATOR

Patients in this arm received Foster® pMDI 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI). Treatment Details: * Dosage: 2 puffs twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily. * Duration: 12 weeks. * Administration: First dose under medical supervision at randomization (Week 0). Blinding \& Control Treatment: * A double-dummy design was used. Patients also received a placebo DPI (matching active DPI), administered as 2 inhalations b.i.d. to maintain blinding. Background Therapy: * Salbutamol was provided as rescue medication. Patient Training \& Compliance: * Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.

Drug: Foster 100/6µg pMDI

Interventions

Foster 100/6µg NEXThaler DRUG

A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).

Also known as: beclometasone dipropionate (BDP) 100 µg / formoterol fumarate (FF) 6 µg NEXThealer

Foster 100/6µg NEXThaler

Foster 100/6µg pMDI DRUG

A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI) with HFA\_134a propellant.

Also known as: beclometasone dipropionate (BDP) 100µg / formoterol fumarate (FF) 6µg pMDI

Foster 100/6µg pMDI

Eligibility Criteria

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

You may qualify if:

• Male or female outpatients, Chinese ethnicity aged ≥18 years, who signed an ICF prior to initiation of any study-related procedure;
• Clinical diagnosis of asthma for a minimum of 6 months prior to V1 (Week -4) confirmed by a chest physician according to international guidelines updated 2018 (GINA) \[1\]. The evidence of asthma had to be confirmed through a documented positive response (in the last 24 months) either to a bronchial provocation test/challenge test or a reversibility test. In case the patient did not have any documented reversibility test or provocation/challenge test, a salbutamol reversibility test was performed at V1 (Week -4) within 10 to 30 minutes after administration of 400 µg of salbutamol pMDI \[17\]. Test response was positive if ΔFEV1 ≥12% and ≥200 mL over baseline.
• Note: In case the reversibility threshold was not met at V1 (Week -4), the test could have been repeated once before V2 or at V2 (Week -2);
• FEV1 \>80% of the predicted normal value after appropriate washout from bronchodilators (checked at V1 \[Week -4\] and at the randomisation visit \[V3, Week 0\]);
• Note: If this criterion was not met:
• At V1 (Week -4), the test could have been repeated once before V2 or at V2 (Week -2);
• At randomisation visit (V3, Week 0), the test could have been repeated once within 2 days after this visit;
• ACQ-6 score \<0.75 (checked at V1 \[Week -4\] and at the randomisation visit \[V3, Week 0\]);
• Patients on previous regular treatment at a stable dose for at least 1 month prior to the screening visit (V1, Week -4) with either medium daily dose of ICS monotherapy (e.g. BDP-chlorofluorocarbons \[CFC\] \>500-1000 µg/day or equivalent dose) or high daily dose of ICS monotherapy (e.g. BDP-CFC \>1000 µg/day or equivalent dose) or low daily dose of ICS (e.g. BDP-CFC ≥200-500 µg/day or equivalent dose)/LABA free/fixed combination or medium daily dose of ICS (e.g. BDP-CFC \>500-1000 µg/day or equivalent dose)/LABA free/fixed combination;
• A cooperative attitude and ability to be trained to the proper use of DPI and pMDI inhalers and an electronic peak flow meter (checked at the screening visit \[V1, Week -4\] and at the randomisation visit \[V3, Week 0\]);
• At least seven valid pre-dose morning PEF measurements in the last 14 days of the run-in period were necessary (checked at the randomisation visit \[V3, Week 0\]).

You may not qualify if:

• 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;
• Sexual abstinence; Reliable contraception had to be maintained throughout the study. Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhoea without an alternative medical cause") or women permanently sterilised (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy) could be enrolled in the study.
• 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, Week -4) and end of treatment (V9, Week 12), urine pregnancy test was performed at all visits except V0 (Week -5) and V9 (Week 12);
• Intermittent asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitiser;
• History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in an intensive care unit);
• Diagnosis of chronic obstructive pulmonary disease as defined by the current global initiative for chronic obstructive lung disease (GOLD) guidelines updated 2016 \[18\];
• Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking 1 year or less prior to screening (V1, Week -4);
• History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease;
• Diagnosis of restrictive lung disease;
• Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1 (Week -4; 3 months for parenteral depot corticosteroids);

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (51)

Chiesi Clinical Trial site 15641

Hefei, Anhui, China

Location

Chiesi Clinical Trial site 15682

Beijing, Beijing Municipality, 100000, China

Location

Chiesi Clinical Trial site 15663

Beijing, Beijing Municipality, 101100, China

Location

Chiesi Clinical Trial site 15662

Foshan, Guangdong, China

Location

Chiesi Clinical Trial site 15671

Guangzhou, Guangdong, 5100150, China

Location

Chiesi clinical Trial Site 15610

Guangzhou, Guangdong, 510120, China

Location

Chiesi clinical Trial site 15656

Guangzhou, Guangdong, China

Location

Chiesi Clinical Trial site 15668

Guangzhou, Guangdong, China

Location

Chiesi Clinical Trial site 15677

Huizhou, Guangdong, 516001, China

Location

Chiesi Clinical Trial site 15683

Shenzhen, Guangdong, 518052, China

Location

Chiesi Clinical Trial site 15608

Shenzhen, Guangdong, China

Location

Chiesi Clinical Trial site 15607

Zhanjiang, Guangdong, 524001, China

Location

Chiesi Clinical Trial site 15610

Guangzhou, Guangzhou, 511400, China

Location

Chiesi Clinical Trial site 15673

Haikou, Hainan, 570208, China

Location

Chiesi Clinical Trial site 15678

Qiqihar, Heilongjiang, 161002, China

Location

Chiesi Clinical Trial site 15681

Xinxiang, Henan, 453000, China

Location

Chiesi Clinical Trial site 15679

Zhengzhou, Henan, 450003, China

Location

Chiesi Clinical Trial site 15614

Wuhan, Hubei, 430030, China

Location

Chiesi Clinical Trial site 15661

Wuhan, Hubei, China

Location

Chiesi Clinical Trial site 15675

Hengyang, Hunan, 421000, China

Location

Chiesi Clinical Trial site 15643

Changzhou, Jiangsu, 213164, China

Location

Chiesi Clinical Trial site 15674

Pingxiang, Jiangxi, 337055, China

Location

Chiesi Clinical Trial site 15676

Jilin City, Jilin, 132011, China

Location

Chiesi clinical Trial site 15621

Shenyang, Liaoning, China

Location

Chiesi clinical Trial site 15619

Nanchang, Nanchang, 330006, China

Location

Chiesi Clinical Trial site 15650

Hohhot, Neimenggu, 010017, China

Location

Chiesi clinical Trial site 15659

Hohhot, Neimenggu, China

Location

Chiesi Clinical Trial site 15630

Shanghai, Shanghai Municipality, 200025, China

Location

Chiesi Clinical Trial site 15664

Shanghai, Shanghai Municipality, 200050, China

Location

Chiesi Clinical Trial site 15654

Shanghai, Shanghai Municipality, 201100, China

Location

Chiesi Clinical Trial site 15630

Shanghai, Shanghai Municipality, China

Location

Chiesi Clinical Trial site 15631

Shanghai, Shanghai Municipality, China

Location

Chiesi Clinical Trial site 15665

Shanghai, Shanghai Municipality, China

Location

Chiesi Clinical Trial site 15625

Taiyuan, Shanxi, 030001, China

Location

Chiesi Clinical Trial site 15611

Shijiazhuang, Shijiazhuang, 050000, China

Location

Chiesi Clinical Trial site 15633

Chengdu, Sichuan, 610041, China

Location

Chiesi Clinical Trial site 15680

Chongqing, Sichuan, 408499, China

Location

Chiesi Clinical Trial site 15642

Tianjin, Tianjin Municipality, 300052, China

Location

Chiesi Clinical Trial site 15634

Tianjin, Tianjin Municipality, 300350, China

Location

Chiesi Clinical Trial site 15626

Xi'an, Xian, 710061, China

Location

Chiesi Clinical Trial site 15672

Beijing, 100144, China

Location

Chiesi clinical Trial site 15636

Beijing, China

Location

Chiesi Clinical Trial site 15638

Chongqing, China

Location

Chiesi Clinical Trial site 15670

Guizhou, China

Location

Chiesi clinical Trial Site 15611

Hebei, China

Location

Chiesi Clinical trial site 15660

Jilin City, China

Location

Chiesi Clinical Trial site 15628

Shanghai, China

Location

Chiesi clinical trial site 15637

Shanghai, China

Location

Chiesi Clinical Trial site 15666

Shenzhen, China

Location

Chiesi clinical Trial site 15633

Sichuan, China

Location

Chiesi Clinical Trial site 15669

Ürümqi, 830054, China

Location

Related Publications (1)

• Zheng J, Zhang J, Fu X, Lin C, Zhang X, Mei X, Corradi M, Cappellini G, Calabro E, Zhu C, Topole E. Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE study. J Asthma. 2024 Apr;61(4):360-367. doi: 10.1080/02770903.2023.2272816. Epub 2023 Nov 1.

  PMID: 37878325 RESULT

Related Links

• Lay Summary of clinical trial results is available both in English and Chinese on the Chiesi Group web-site, along with a copy of the CSR synopsis.

MeSH Terms

Conditions

Asthma

Interventions

Foster Home Care; Beclomethasone; alpha-ketoisovalerate dehydrogenase phosphatase; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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

Results Point of Contact

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

clinicaltrials_info@chiesi.com

+39 0521 2791

Study Officials

• Jinping MD Zheng

  The First Affiliated Hospital of Guangzhou Medical University

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 5, 2018
• Study Start: October 9, 2017
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: August 10, 2026
• Results First Posted: August 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (51)