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New inhaler combo shows promise for Hard-to-Control asthma

NCT ID NCT02127866

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adding a drug called glycopyrrolate to a standard asthma inhaler (Foster) helps people whose asthma is not well controlled. 211 adults with uncontrolled asthma took part. The main goal was to see if the combination improved lung function over 12 hours. The study was completed and focused on managing asthma symptoms, not curing the disease.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

211 people

The number who actually took part.

Started

Apr 2014

Finished

Mar 2015

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: For inclusion into the study, patients were required to fulfil all of the following criteria: 1. Patient's written informed consent obtained prior to any study-related procedures; 2. Male or female patients aged ≥18; 3. Patients with uncontrolled asthma on 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; Drug\* Medium daily dose BDP non-extrafine \>500 - 1000 μg BDP extrafine \>250 - 500 μg Budesonide \>400 - 800 μg Ciclesonide \>160 - 320 μg Fluticasone \>250 - 500 μg Mometasone ≥400 μg - \< 800 μg \*In this table (adapted from GINA 2012) the recommendations for doses of inhaled glucocorticosteroids are given as "μg/day budesonide or equivalent" 4. Patients with a pre-bronchodilator FEV1 ≥40% and \<80% of their predicted normal value, after appropriate wash-out 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 within 30 minutes after administration of 400 μg of salbutamol pMDI, defined as ΔFEV1 ≥12% and ≥200 mL over Baseline; Note: In case the reversibility threshold is not met, the test can be performed once before randomisation. 6. Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire® (ACQ) ≥1.5 (criterion must be met at Screening and at the end of the run-in period); 7. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI. At pre-Screening visit (V0) the patient's written informed consent (criterion 1) was obtained and then at the Screening visit (V1), all the above-mentioned inclusion criteria were checked. At the Randomisation visit (Visit P1D1 \[V2\]), the following inclusion criteria were re-checked: 4, 6 and 7. Exclusion Criteria: Patients were not enrolled 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. History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations which, in the judgement of the Investigator, may have placed the patient at undue risk; 3. Hospitalisation, emergency room admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to Screening visit and during the run-in period; 4. Lower respiratory tract infection in the 4 weeks before the Screening visit or during the run-in period; 5. Patients who were in therapy for gastroesophageal reflux disease (GERD) and/or patients with a medical history of GERD that led to asthma symptoms; 6. Patients with a seasonal worsening of asthma and who were not able to complete the study outside the relevant allergen season; 7. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may have interfered with data evaluation; 8. Patients who suffered from COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 9. Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years and /or having stopped smoking one year or less prior to Screening visit; 10. Any change in dose, schedule, formulation of ICS + LABAs in the 4 weeks prior to Screening visit; 11. Patients used to be or treated with inhaled long-acting antimuscarinic drugs; 12. Patients treated with anti-IgE antibodies; 13. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS were using one or more of the following reliable methods of contraception: * Placement of an intra uterine device (IUD) or intra uterine system (IUS); * Hormonal contraception (implantable, patch, oral); * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository. Reliable contraception was maintained throughout the study. Pregnancy tests were performed at study entry (a serum one at Screening visit and a urine one at Screening and Randomisation visits) in all women of childbearing potential. Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhea") or women permanently sterilized (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) were allowed to be enrolled in the study. 14. Patients who have received an investigational drug within 2 months before Screening visit; 15. Patients who had clinically significant (CS) cardiovascular condition according to Investigator's judgement, such as but not limited to: congestive heart failure (New York Heart Association \[NYHA\] class \>3), acute ischemic heart disease in the last year prior to study Screening, history of sustained cardiac arrhythmias or sustained and nonsustained cardiac arrhythmias diagnosed in the last 6 months (sustained means lasting more than 30 seconds and or ending only with external action, and or leads to hemodynamic collapse; non-sustained means \> 3 beats \< 30 seconds, and or ending spontaneously, and or asymptomatic), impulse conduction blocks. Similarly, patients affected by permanent or paroxysmal atrial fibrillation were not considered for enrolment; 16. An abnormal and CS 12-lead electrocardiogram (ECG) that resulted in active medical problem which may have impacted the safety of the patient according to Investigator's judgement; 17. Patients whose electrocardiogram (12-lead ECG) showed Fridericia-Corrected QTc (QTcF) \>450 millisecond (ms) for males or QTcF \>470 ms for females at Screening or at Randomisation visits; 18. Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator, would have prevented use of anticholinergic agents; 19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may 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; 20. Patients having received a live-attenuated virus vaccination within two 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); 21. Patients mentally or legally incapacitated; 22. Patients with a history of alcohol or drug abuse; 23. Patients with known intolerance/hypersensitivity or contra-indication to treatment with ß2-agonists, inhaled corticosteroids, anti-cholinergics or propellant gases/excipients; 24. Patients with major surgery in the 3 months prior to Screening visit and/or planned surgery during the trial; 25. Patients treated with non-potassium sparing diuretics (association with potassium sparing diuretics was allowed), non-selective β-blocking drugs, quinidine, quinidine-like anti arrhythmics, or any medication with a QTc prolongation potential or a history of QTc prolongation; 26. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants; 27. Patients who were receiving any therapy that could have interfered with the study drugs according to Investigator's opinion. At the Screening visit (V1), all the above-mentioned exclusion criteria were checked. At the Randomisation visit (Visit P1D1 \[V2\], the following exclusion criteria were re-checked: 1, 3, 4, 5, 13, 16, 17, 19, 20, 24 and 27.

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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 0101

    Rousse, 7002, Bulgaria

  • Chiesi Clinical Trial Site 0102

    Sofia, 1407, Bulgaria

  • Chiesi Clinical Trial Site 0103

    Stara Zagora, 6003, Bulgaria

  • Chiesi Clinical Trial Site 0104

    Troyan Municipality, 5600, Bulgaria

  • Chiesi Clinical Trial Site 0105

    Dupnitsa, 2600, Bulgaria

  • Chiesi Clinical Trial Site 0106

    Sevlievo, 5400, Bulgaria

  • Chiesi Clinical Trial Site 0107

    Sofia, 1233, Bulgaria

  • Chiesi Clinical Trial Site 0108

    Sofia, 1336, Bulgaria

  • Chiesi Clinical Trial Site 0109

    Sofia, 1432, Bulgaria

  • Chiesi Clinical Trial Site 0110

    Sofia, 1431, Bulgaria

  • Chiesi Clinical Trial Site 0201

    Leipzig, 04357, Germany

  • Chiesi Clinical Trial Site 0202

    Magdeburg, 39112, Germany

  • Chiesi Clinical Trial Site 0203

    Lübeck, 23552, Germany

  • Chiesi Clinical Trial Site 0204

    Radebeul, 01445, Germany

  • Chiesi Clinical Trial Site 0206

    Großhansdorf, 22927, Germany

  • Chiesi Clinical Trial Site 0207

    Berlin, 12165, Germany

  • Chiesi Clinical Trial Site 0208

    Berlin, 10787, Germany

  • Chiesi Clinical Trial Site 0210

    Witten, 58452, Germany

  • Chiesi Clinical Trial Site 0301

    Siófok, 8600, Hungary

  • Chiesi Clinical Trial Site 0302

    Budapest, 1122, Hungary

  • Chiesi Clinical Trial Site 0303

    Komárom, 2900, Hungary

  • Chiesi Clinical Trial Site 0304

    Deszk, 6772, Hungary

  • Chiesi Clinical Trial Site 0305

    Gödöllő, 2100, Hungary

  • Chiesi Clinical Trial Site 0306

    Szarvas, 5540, Hungary

  • Chiesi Clinical Trial Site 0307

    Balassagyarmat, 2660, Hungary

  • Chiesi Clinical Trial Site 0401

    Pisa, 56124, Italy

  • Chiesi Clinical Trial Site 0402

    Parma, 43125, Italy

  • Chiesi Clinical Trial Site 0403

    Brescia, 25123, Italy

  • Chiesi Clinical Trial Site 0404

    Verona, 37134, Italy

  • Chiesi Clinical Trial Site 0408

    Trieste, 34149, Italy

  • Chiesi Clinical Trial Site 0501

    Oświęcim, 32-600, Poland

  • Chiesi Clinical Trial Site 0502

    Giżycko, 11-500, Poland

  • Chiesi Clinical Trial Site 0503

    Ostróda, 14-100, Poland

  • Chiesi Clinical Trial Site 0504

    Wroclaw, 51-162, Poland

  • Chiesi Clinical Trial Site 0505

    Lodz, 90-141, Poland

  • Chiesi Clinical Trial Site 0506

    Proszowice, 32-100, Poland

  • Chiesi Clinical Trial Site 0507

    Gdansk, 80-847, Poland

  • Chiesi Clinical Trial Site 0508

    Rzeszów, 35-241, Poland

  • Chiesi Clinical Trial Site 0509

    Lodz, 90-153, Poland

  • Chiesi Clinical Trial Site 0510

    Bialystok, 15-430, Poland

  • Chiesi Clinical Trial Site 0511

    Krakow, 31-637, Poland

  • Chiesi Clinical Trial Site 0512

    Lublin, 20-718, Poland

  • Chiesi Clinical Trial Site 0601

    Manchester, M23 9QZ, United Kingdom

  • Chiesi Clinical Trial Site 0602

    London, W1G 8HU, United Kingdom

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