A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: COPD, Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.

Key facts

Study ID

NCT03084796

Run by

Chiesi Farmaceutici S.p.A.

People needed

733

Starts

2017-07-28

Expected to finish

2018-06-06

Last updated by the study team

2021-06-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged ≥ 40 who have signed an Informed Consent Form prior to initiation of any study-related procedure.
• Subjects with a diagnosis of COPD (according to GOLD 2017 Global Strategy for the Diagnosis, Management and Prevention of COPD Report) at least 12 months before the screening visit.
• Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
• A post-bronchodilator forced expiratory volume in the 1st second (FEV1) ≥50% and <80% of the predicted normal value and,
• a post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7 at screening and
• a demonstrated reversibility to ipratropium defined as ΔFEV1 ≥ 5% over baseline 30-45 minutes after inhaling 4 puffs of ipratropium
• Subjects under regular COPD therapy for at least 2 months prior to screening with either inhaled long-acting muscarinic antagonist (LAMA), inhaled ICS/ long-acting β2-agonist (LABA), inhaled ICS + LAMA
• Symptomatic subjects at screening with a CAT score ≥10. This criterion must be confirmed at randomization
• Symptomatic subjects with a BDI focal score ≤ 10. This criterion must be confirmed at randomization
• A cooperative attitude and ability to demonstrate correct use of the inhalers and e-diary.

You may not qualify if…

• Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS they are willing to use highly effective birth control methods
• Diagnosis of asthma or Asthma-COPD Overlap Syndrome (ACOS) as described in global initiative for asthma (GINA) Report 2016, history of allergic rhinitis or atopy (atopy which may raise contra-indications or impact the efficacy of the study treatment according to Investigator's judgment)
• COPD Exacerbations: a moderate or severe COPD exacerbation that has not resolved ≤14 days prior to screening and ≤30 days following the last dose of any oral/systemic corticosteroid or antibiotic (whichever comes last). A Moderate or Severe COPD exacerbation during the run-in period
• Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening or during run-in
• Subjects treated with non-cardio-selective β-blockers in the month preceding screening or during the run-in period
• Subjects treated with long-acting anti-histamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as needed
• Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
• Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according the Investigator's judgment.
• Subjects who have clinically significant cardiovascular condition
• Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement
• Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females at screening visit
• Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would prevent use of anticholinergic agents
• History of hypersensitivity to M3 receptor antagonists, β2-adrenergic receptor agonist, corticosteroids or any of the excipients contained in any of the formulations used in the study which may raise contra-indications or impact the efficacy of the study treatment according to the Investigator's judgement
• Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study treatment according to Investigator's judgement
• Subjects with serum potassium levels <3.5 mEq/L (or 3.5 mmol/L) at screening
• Use of potent cytochrome P450 2D6 and 3A4 inhibitors within 4 weeks prior to screening
• Unstable or uncontrolled concurrent disease; fever, endocrine disease, gastrointestinal disease; neurological disease; hematological disease; autoimmune disorders, or other which may impact the feasibility of the results of the study according to Investigator's judgment
• History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening
• Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
• Subjects who are mentally or legally incapacitated, or subjects accommodated in an establishment as a result of an official or judicial order.
• Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.

Where it is running

• Chiesi Investigational Site — Dothan, Alabama, United States
• Chiesi Investigational Site — Montgomery, Alabama, United States
• Chiesi Investigational Site — Flagstaff, Arizona, United States
• Chiesi Investigational Site — Glendale, Arizona, United States
• Chiesi Investigational Site — Phoenix, Arizona, United States
• Chiesi Investigational Site — Phoenix, Arizona, United States
• Chiesi Investigational Site — Phoenix, Arizona, United States
• Chiesi Investigational Site — Surprise, Arizona, United States
• Chiesi Investigational Site — Tempe, Arizona, United States
• Chiesi Investigational Site — Tucson, Arizona, United States
• Chiesi Investigational Site — Anaheim, California, United States
• Chiesi Investigational Site — Escondido, California, United States
• Chiesi Investigational Site — Fullerton, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Chiesi Investigational Site — Long Beach, California, United States
• Chiesi Investigational Site — Los Angeles, California, United States
• Chiesi Investigational Site — Los Angeles, California, United States
• Chiesi Investigational Site — Los Angeles, California, United States
• Chiesi Investigational Site — Newport Beach, California, United States
• Chiesi Investigational Site — San Diego, California, United States
• Chiesi Investigational Site — Tustin, California, United States
• Chiesi Investigational Site — Westminster, California, United States
• Chiesi Investigational Site — Boulder, Colorado, United States
• Chiesi Investigational Site — Centennial, Colorado, United States
• Chiesi Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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