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New combo inhaler breathes better for tough asthma cases

NCT ID NCT01577082

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a combination inhaler (CHF 1535, containing both a steroid and a long-acting bronchodilator) works better than a steroid-only inhaler in adults whose asthma is not well controlled despite high-dose steroids or medium-dose steroids plus another bronchodilator. Over 12 weeks, 542 participants measured their morning peak flow (a measure of lung function) daily. The goal was to see if the combination inhaler improved lung function more than the steroid alone.

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

542 people

The number who actually took part.

Started

Apr 2012

Finished

Nov 2012

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. Patient's written informed consent obtained prior to any study-related procedures; 2. Male or female patients aged \>=18; 3. Patients with persistent asthma not optimally controlled (GINA 2010 'Management Approach Based on Control') on high doses of ICS (1000-2000 μg daily dose BDP non-extrafine or equivalent) or medium doses of ICS+LABA (500-1000 μg daily dose BDP non-extrafine or equivalent plus formoterol 24 μg or salmeterol 100 μg) at a stable dose for at least 4 weeks prior to screening; Equivalence to Medium dose High dose BDP non-extrafine 500-1000 μg \> 1000-2000 μg BDP extrafine 200-400 μg \> 400-800 μg Budesonide 400-800 μg \> 800-1600 μg Ciclesonide 160-320 μg \> 320-1280 μg Fluticasone 250-500 μg \> 500-1000 μg Mometasone 400-800 μg \> 800-1200 μg 4. Patients with a FEV1 \> = 40% and \< 80% of patient's predicted normal value and an absolute value of at least 0.9 L, after appropriate washout from bronchodilators at screening and at the end of the run-in period; 5. Patients with a positive response to the reversibility test at screening, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI. In case this reversibility threshold was not met, the FEV1 reversibility test could be performed once before randomisation, after an appropriate wash-out from bronchodilators. Alternatively, a documented positive response to reversibility, as defined above, within the 3 months prior to the screening visit was acceptable; 6. Patients with not adequately controlled asthma evidenced by: a. At least one of the following at any week in the 2 previous weeks (in addition to FEV1 \< 80% of the predicted normal value) had to be present: i. Daytime symptoms more than twice/week; ii. Any limitations of activities; iii. Nocturnal symptoms/awakening; iv. Need for reliever/rescue treatment more than twice/week; b. And a score at the Asthma Control Questionnaire© (ACQ) \> 0.75. Both of the above had to be met at screening and at the end of the run-in period; 7. Presence of at least 7 available pre-dose morning PEF measurements in the run-in period; 8. Patients with a cooperative attitude and ability to be trained to correctly use the pMDI and a portable electronic peak flow meter; 9. For France only: only patients registered under a social welfare could be included in the study. Exclusion Criteria: Patients were not enrolled in the study if one or more of the following criteria were present: 1. Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake; 2. Seasonal (intermittent) asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitiser; 3. History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations (3 or more asthma exacerbations/year) which, in the judgement of the Investigator, could have placed the patient at undue risk; 4. Hospitalisation, emergency room (ER) admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to the screening visit and during the run-in period; 5. Lower respiratory tract infection in the 4 weeks before the screening visit; 6. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which could have interfered with data evaluation; 7. Patients who suffered from Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 8. Current smokers or ex-smokers with total cumulative exposure equal or more than 5 pack-years and/or who stopped smoking one year or less prior to screening visit; 9. Any change in dose, schedule, formulation of ICS or ICS+LABAs in the 4 weeks prior to the screening visit; 10. Patients who were treated with anti-IgE antibodies; 11. Patients who were treated with long acting anti-cholinergics (tiotropium); 12. Patients who used any of the following medications prior to the screening visit and had not met the specified minimum wash-out period: 1. Short-acting β2-agonists: 6 hours; 2. LABA: 12 hours; 3. Fixed combinations of an anti-cholinergic and short-acting β2-agonist: 12 hours; 4. Short-acting anti-cholinergic: 12 hours; 5. Systemic corticosteroids: 4 weeks; 6. Slow release corticosteroids: 12 weeks; 13. Pregnant or lactating women or women at risk of pregnancy i.e. not using one or more of the following acceptable methods of contraception: 1. Surgical sterilisation (e.g. bilateral tubal ligation, hysterectomy); 2. Hormonal contraception (implantable, injectable, patch, oral); 3. Double-barrier methods (any double combination of: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) Post-menopausal women, i.e. women with at least 12 months of natural (spontaneous) amenorrhea or at least 6 months of spontaneous amenorrhea with documented serum follicle-stimulating hormone levels \> 40 mIU/mL, could be enrolled. A serum pregnancy test was performed at the screening visit in women of childbearing potential; 14. Patients who had received an investigational drug within 2 months before screening visit; 15. Patients with a significant history or current evidence of heart failure, cardiomyopathy, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease which, in the judgement of the Investigator, could have placed the patient at undue risk; 16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could have increased the risk associated with study participation or study drug administration and, in the judgment of the Investigator, would have made the patient inappropriate for entry into this study, placed the patients at undue risk or potentially compromised the results or interpretation of the study; 17. Patients with a clinically significant abnormality at 12-lead electrocardiogram (ECG) or presenting a Fridericia-correct QT (QTcF) interval value \> 450 msec in males or \> 470 msec in females; 18. Patients who received a live-attenuated virus vaccination within 2 weeks prior to screening or during the run-in (inactivated influenza vaccination was acceptable provided it was not administered less than 48 hours prior to screening); 19. Patients mentally or legally incapacitated; 20. Patients with a history of alcohol or drug abuse; 21. Patients with known intolerance/hypersensitivity or contra-indication to treatment with beta-2-agonists, ICSs or propellant gases/excipients; 22. Patients with major surgery in the 3 months prior to the screening visit and/or planned surgery during the trial; 23. Patients treated with non-potassium sparing diuretics (association with potassium sparing diuretics was allowed), non-selective beta-blocking drugs, quinidine, quinidine-like anti arrhythmics, or any medication with a corrected QT (QTc) prolongation potential or a history of QTc prolongation; 24. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, unless already taken at stable doses for at least 4 weeks before the screening visit and evidence of a normal QTc interval under these medications; 25. Patients who were receiving any therapy that could have interfered with the study drugs according to the Investigator's opinion.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

  • Chiesi Clinica Trial Site

    Witten, 58452, Germany

  • Chiesi Clinica Trial Site

    Yaroslavl, 150030, Russia

  • Chiesi Clinical Trial

    Perpignan, 66000, France

  • Chiesi Clinical Trial SIte

    Sofia, 1618, Bulgaria

  • Chiesi Clinical Trial SIte

    Varna, 9010, Bulgaria

  • Chiesi Clinical Trial Site

    Plovdiv, 4004, Bulgaria

  • Chiesi Clinical Trial Site

    Plovdiv, 4023, Bulgaria

  • Chiesi Clinical Trial Site

    Rousse, 5402, Bulgaria

  • Chiesi Clinical Trial Site

    Rousse, 7002, Bulgaria

  • Chiesi Clinical Trial Site

    Sofia, 1000, Bulgaria

  • Chiesi Clinical Trial Site

    Sofia, 1407, Bulgaria

  • Chiesi Clinical Trial Site

    Sofia, 1510, Bulgaria

  • Chiesi Clinical Trial Site

    Sofia, 1606, Bulgaria

  • Chiesi Clinical Trial Site

    Stara Zagora, 6000, Bulgaria

  • Chiesi Clinical Trial Site

    Troyan Municipality, 5600, Bulgaria

  • Chiesi Clinical Trial Site

    Varna, 1510, Bulgaria

  • Chiesi Clinical Trial Site

    Mělník, 27601, Czechia

  • Chiesi Clinical Trial Site

    Neratovice, 27711, Czechia

  • Chiesi Clinical Trial Site

    Prague, 14000, Czechia

  • Chiesi Clinical Trial Site

    Toulon, 83000, France

  • Chiesi Clinical Trial Site

    Berlin, 10117, Germany

  • Chiesi Clinical Trial Site

    Berlin, 12043, Germany

  • Chiesi Clinical Trial Site

    Bonn, 53119, Germany

  • Chiesi Clinical Trial Site

    Düren, 52349, Germany

  • Chiesi Clinical Trial Site

    Hamburg, 20251, Germany

  • Chiesi Clinical Trial Site

    Leipzig, 04207, Germany

  • Chiesi Clinical Trial Site

    Leipzig, 04357, Germany

  • Chiesi Clinical Trial Site

    Magdeburg, 39112, Germany

  • Chiesi Clinical Trial Site

    Radebeul, 01445, Germany

  • Chiesi Clinical Trial Site

    Saarbrücken, 66111, Germany

  • Chiesi Clinical Trial Site

    Schwabach, 91126, Germany

  • Chiesi Clinical Trial Site

    Budapest, H-1122, Hungary

  • Chiesi Clinical Trial Site

    Dabas, 2370, Hungary

  • Chiesi Clinical Trial Site

    Deszk, 6772, Hungary

  • Chiesi Clinical Trial Site

    Gödöllő, 21100, Hungary

  • Chiesi Clinical Trial Site

    Komárom, 2900, Hungary

  • Chiesi Clinical Trial Site

    Pécs, 7624, Hungary

  • Chiesi Clinical Trial Site

    Siófok, 8600, Hungary

  • Chiesi Clinical Trial Site

    Százhalombatta, 2440, Hungary

  • Chiesi Clinical Trial Site

    Szolnok, 5000, Hungary

  • Chiesi Clinical Trial Site

    Padova, 35013, Italy

  • Chiesi Clinical Trial Site

    Parma, 43125, Italy

  • Chiesi Clinical Trial Site

    Pisa, 56124, Italy

  • Chiesi Clinical Trial Site

    Pordenone, 323170, Italy

  • Chiesi Clinical Trial Site

    Verona, 37134, Italy

  • Chiesi Clinical Trial Site

    Bialystok, 15025, Poland

  • Chiesi Clinical Trial Site

    Bialystok, 15274, Poland

  • Chiesi Clinical Trial Site

    Bienkówka, 34200, Poland

  • Chiesi Clinical Trial Site

    Gdansk, 80847, Poland

  • Chiesi Clinical Trial Site

    Giżycko, 11500, Poland

  • Chiesi Clinical Trial Site

    Gmina Jędrzejów, 28300, Poland

  • Chiesi Clinical Trial Site

    Katowice, 40752, Poland

  • Chiesi Clinical Trial Site

    Katowice, 40952, Poland

  • Chiesi Clinical Trial Site

    Lodz, 90153, Poland

  • Chiesi Clinical Trial Site

    Lodz, 92107, Poland

  • Chiesi Clinical Trial Site

    Lublin, 20718, Poland

  • Chiesi Clinical Trial Site

    Ostróda, 14100, Poland

  • Chiesi Clinical Trial Site

    Ostrów Wielkopolski, 63400, Poland

  • Chiesi Clinical Trial Site

    Rzeszów, 35051, Poland

  • Chiesi Clinical Trial Site

    Moscow, 109147, Russia

  • Chiesi Clinical Trial Site

    Moscow, 117593, Russia

  • Chiesi Clinical Trial Site

    Saratov, 410000, Russia

  • Chiesi Clinical Trial Site

    Birmingham, B15 2SQ, United Kingdom

  • Chiesi Clinical Trial Site

    Chorley, PR7 7NA, United Kingdom

  • Chiesi Clinical Trial Site

    Manchester, M15 6SE, United Kingdom

  • Chiesi Clinical trial

    Marmande, 47200, France

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