Clinical study to evaluate the effects of nacystelyn in COPD patients by using Functional respiratory Imaging.

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 20.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-001160-29-BE
• Lead Sponsor: ABORATOIRES SMB S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-07
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Patient is able to give signed written informed consent prior to study entry.
2.Male or female patients 40 – 85 years, inclusive, as of the screening visit.
3.Patient is an ex-smoker with a minimum 10 pack-years of historical use (the equivalent of one pack per day for 10 years).
4.Patient has a diagnosis of COPD according to the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria with a postbronchodilator FEV1 of 25 - 60% of predicted and a FEV1/FVC<0.7.
5.Patients has the ability to perform acceptable and repeatable spirometry according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria and/or protocol-defined criteria.
6.Patient is able to withhold rescue medication for at least 6 hours prior to the study visits.
7.Patient is free of any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
8.Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
9. Patient must be able to use the study inhaler device (Axahaler®).
10.If female, is currently not pregnant, not breast feeding, has a negative urine pregnancy test and is of
•nonchildbearing potential, defined as:
- 1 year post-menopausal
- surgically sterile (tubal ligation, oophorectomy, or hysterectomy)
- diagnosed as infertile and not undergoing treatment to reverse infertility
or is of
•childbearing potential, has a negative urine pregnancy test at the screening visit and willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
- systemic contraception used for 1 month prior to screening, including birth control pills, transdermal patch (EVRA® or equivalent), vaginal ring (NUVARING® or equivalent), levonorgestrel implant (NORPLANT® or equivalent), or injectable progesterone (DEPO-PROVERA® or equivalent)
- double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide)
- intra-uterine device with a low failure rate <1% per year
- monogamous with a vasectomized male partner or exclusively has same-sex partners.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1.Known respiratory disorder other than COPD, including but not limited to the following: alpha-1-antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary oedema, or interstitial lung disease, known active tuberculosis.
2.Evidence or history of other clinically significant disease or abnormality that in the opinion of the Investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
3.Hospitalization for a COPD exacerbation or pneumonia within 6 weeks prior to the screening visit.
4.Treatment for a non-hospitalized COPD exacerbation or pneumonia requiring antibiotics and/or systemic corticosteroids within 4 weeks prior to the screening visit.
5.The patient is pregnant or lactating, or plans to become pregnant or donate gametes (ova or sperm) during the study period or for 30 days after the patient’s last study-related visit (for eligible patients only, if applicable). Eligible female and male patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
6.Treatment with oral, intravenous, or intramuscular corticosteroids within 4 weeks prior to the screening visit.
7.Inability to discontinue prohibited medications during the screening, run-in and treatment periods.
8.Documented or suspected viral or bacterial, upper respiratory infection (URI) or lower respiratory infection (LRI), sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 4 weeks prior to the screening visit.
9.Patient did experience an AE that, in the opinion of the Investigator, would result in failure to meet the inclusion/exclusion criteria during the screening period.
10.History of allergy or hypersensitivity to acetylcysteine, anticholinergic/ muscarinic receptor antagonist agent, beta-2 agonists, mannitol, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
11.Factors (e.g. infirmity, disability, or geographic location) that the Investigator feels would likely limit the patient's compliance with the study protocol or study visits.
12.Current evidence or known history of alcohol or substance abuse within 2 years of the screening visit.
13.Patient is either an employee of the investigational center or an immediate relative of an employee of the investigational center.
14.History of lung volume reduction surgery within the previous 12 months prior to the screening visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified