Can a Breath-Activated inhaler match the standard for asthma control?

NCT ID NCT03453112

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

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a breath-activated dry powder inhaler (NEXThaler) delivers the same asthma control as a traditional pressurized inhaler (pMDI), both containing the same combination of medications (beclometasone and formoterol). Adults with well-controlled asthma will use one of the two devices twice daily for 12 weeks. Researchers will measure morning peak flow to see if the two devices perform equally well, along with other lung function and safety checks.

What this could mean

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

Active substance: A fixed combination of beclometasone dipropionate (an inhaled corticosteroid) and formoterol fumarate (a long-acting bronchodilator), delivered via two different inhaler devices.
What this could lead to: If the breath-actuated inhaler works as well as the traditional one, it could offer people with asthma a more convenient and reliable way to take their daily controller medication.
What could go wrong: This is a non-inferiority trial, so it aims to show the new device is not worse than the existing one, not that it is better. Results may not apply to all asthma patients, and individual responses can vary.

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

494 people

The number who actually took part.

Started

Oct 2017

Finished

Dec 2021

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

18 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: 1. Male or female outpatients, Chinese ethnicity aged ≥18 years, who signed an ICF prior to initiation of any study-related procedure; 2. 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); 3. 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; 4. ACQ-6 score \<0.75 (checked at V1 \[Week -4\] and at the randomisation visit \[V3, Week 0\]); 5. 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; 6. 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 \[V3, Week 0\]); 7. 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 \[V3, Week 0\]). Exclusion Criteria: 1. 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); 2. Intermittent asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitiser; 3. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in an intensive care unit); 4. Diagnosis of chronic obstructive pulmonary disease as defined by the current global initiative for chronic obstructive lung disease (GOLD) guidelines updated 2016 \[18\]; 5. 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); 6. Severe asthma exacerbation leading to intake of systemic corticosteroids (≥10 days) within 1 month prior to inclusion or moderate/severe asthma exacerbation (according to international guidelines updated 2018 \[GINA\] \[1\]) during the run-in period (checked at the screening visit \[V1, Week -4\] and at the randomisation visit \[V3, Week 0\]); 7. Lower respiratory tract infections (e.g. pneumonia) affecting the patient's asthma within 1 month prior to inclusion; 8. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease; 9. Diagnosis of restrictive lung disease; 10. Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1 (Week -4; 3 months for parenteral depot corticosteroids); 11. Intolerance or contra-indication to treatment with β2-agonists and/or ICS or allergy to any component of the study treatments; 12. Having received an investigational medication within 2 months before screening (V1, Week -4); 13. Patients who had a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition (e.g. major surgery) that might have, in the judgment of the Investigator, represented for the patients an undue risk or that could have compromised the results or interpretation of the study; 14. History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias; 15. Clinically relevant laboratory abnormalities such as (but not limited to) hypokalaemia (\<3.5 mEq/L), that might have compromised patient's safety or compliance, interfered with evaluation, or precluded completion of the study, in the judgment of the Investigator. Patients with uncontrolled diabetes including patients with a history of fasting plasma glucose levels consistently out of the normal range (\>140 mg/dL) or HbA1C \>8%; 16. Patients who had an abnormal 12-lead ECG (i.e. QRS interval \[QRS\] \>120 ms and/or PR interval \[PR\] \>210 ms and/or HR \<45 beats per minute \[bpm\] and/or HR \>110 bpm and/or Fridericia-corrected QT interval \[QTcF\] \>450 ms for males or QTcF \>470 ms for females) or 12-lead ECG evaluated as abnormal clinically significant (CS) by the Investigator, at screening (V1, Week -4); 17. Patients who had a concomitant disease of poor prognosis (e.g. cancer); 18. Patients treated with monoclonal antibodies (e.g. anti-immunoglobulin E \[anti-IgE\] antibodies); 19. Patients treated with non-potassium sparing diuretics (unless administered at a fixed dose combination with a potassium conserving medication), non-selective β1-blocking medications, quinidine, quinidine-like antiarrhythmics or any medication with a corrected QT interval (QTc) prolongation potential, or a history of QTc prolongation; 20. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, unless already taken at stable doses in the month before screening (V1, Week -4) and without any safety concern; 21. Patients who were receiving therapy that could interact with steroids, such as enzyme inhibitors (macrolides, antifungal therapy \[not topical\]) or inducers (anticonvulsants, rifampicin); 22. Inability to comply with study procedures or with study treatment intake.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

Chiesi Clinical Trial site 15607

Zhanjiang, Guangdong, 524001, China
Chiesi Clinical Trial site 15608

Shenzhen, Guangdong, China
Chiesi Clinical Trial site 15610

Guangzhou, Guangzhou, 511400, China
Chiesi Clinical Trial site 15611

Shijiazhuang, Shijiazhuang, 050000, China
Chiesi Clinical Trial site 15614

Wuhan, Hubei, 430030, China
Chiesi Clinical Trial site 15625

Taiyuan, Shanxi, 030001, China
Chiesi Clinical Trial site 15626

Xi'an, Xian, 710061, China
Chiesi Clinical Trial site 15628

Shanghai, China
Chiesi Clinical Trial site 15630

Shanghai, Shanghai Municipality, 200025, China
Chiesi Clinical Trial site 15630

Shanghai, Shanghai Municipality, China
Chiesi Clinical Trial site 15631

Shanghai, Shanghai Municipality, China
Chiesi Clinical Trial site 15633

Chengdu, Sichuan, 610041, China
Chiesi Clinical Trial site 15634

Tianjin, Tianjin Municipality, 300350, China
Chiesi Clinical Trial site 15638

Chongqing, China
Chiesi Clinical Trial site 15641

Hefei, Anhui, China
Chiesi Clinical Trial site 15642

Tianjin, Tianjin Municipality, 300052, China
Chiesi Clinical Trial site 15643

Changzhou, Jiangsu, 213164, China
Chiesi Clinical Trial site 15650

Hohhot, Neimenggu, 010017, China
Chiesi Clinical Trial site 15654

Shanghai, Shanghai Municipality, 201100, China
Chiesi Clinical Trial site 15661

Wuhan, Hubei, China
Chiesi Clinical Trial site 15662

Foshan, Guangdong, China
Chiesi Clinical Trial site 15663

Beijing, Beijing Municipality, 101100, China
Chiesi Clinical Trial site 15664

Shanghai, Shanghai Municipality, 200050, China
Chiesi Clinical Trial site 15665

Shanghai, Shanghai Municipality, China
Chiesi Clinical Trial site 15666

Shenzhen, China
Chiesi Clinical Trial site 15668

Guangzhou, Guangdong, China
Chiesi Clinical Trial site 15669

Ürümqi, 830054, China
Chiesi Clinical Trial site 15670

Guizhou, China
Chiesi Clinical Trial site 15671

Guangzhou, Guangdong, 5100150, China
Chiesi Clinical Trial site 15672

Beijing, 100144, China
Chiesi Clinical Trial site 15673

Haikou, Hainan, 570208, China
Chiesi Clinical Trial site 15674

Pingxiang, Jiangxi, 337055, China
Chiesi Clinical Trial site 15675

Hengyang, Hunan, 421000, China
Chiesi Clinical Trial site 15676

Jilin City, Jilin, 132011, China
Chiesi Clinical Trial site 15677

Huizhou, Guangdong, 516001, China
Chiesi Clinical Trial site 15678

Qiqihar, Heilongjiang, 161002, China
Chiesi Clinical Trial site 15679

Zhengzhou, Henan, 450003, China
Chiesi Clinical Trial site 15680

Chongqing, Sichuan, 408499, China
Chiesi Clinical Trial site 15681

Xinxiang, Henan, 453000, China
Chiesi Clinical Trial site 15682

Beijing, Beijing Municipality, 100000, China
Chiesi Clinical Trial site 15683

Shenzhen, Guangdong, 518052, China
Chiesi Clinical trial site 15660

Jilin City, China
Chiesi clinical Trial Site 15610

Guangzhou, Guangdong, 510120, China
Chiesi clinical Trial Site 15611

Hebei, China
Chiesi clinical Trial site 15619

Nanchang, Nanchang, 330006, China
Chiesi clinical Trial site 15621

Shenyang, Liaoning, China
Chiesi clinical Trial site 15633

Sichuan, China
Chiesi clinical Trial site 15636

Beijing, China
Chiesi clinical Trial site 15656

Guangzhou, Guangdong, China
Chiesi clinical Trial site 15659

Hohhot, Neimenggu, China
Chiesi clinical trial site 15637

Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.