A

Phase 1

• Conditions: COPD (Chronic Obstructive Pulmonary Disease); MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002356-20-HU
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-11
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subject’s signed Informed Consent Form obtained prior to any study-related procedure;
2. Male or female = 40 years of age;
3. Current smokers and/or ex-smokers of at least 10 pack-years
4. Established diagnosis of COPD according to the 2020 GOLD Report, prior to the Screening visit (V1);
5. Post-BD FEV1/FVC < 0.7 and FEV1 = 60% of predicted at V1
6. On a stable dose of any non-extrafine ICS/LABA DPI twice daily regimen for at least 8 weeks before screening;
7. Presence of lung hyperinflation based on the increase of Total Lung Capacity (TLC) exceeding either the upper limit of normal (ULN) or an empiric 120% of predicted, and/or a plethysmographic functional residual capacity (FRC) exceeding either ULN or 120 % of predicted;
8. Symptomatic subjects with CAT score = 10 at V1 and V2;
9. Documented history of = 1 moderate or severe COPD exacerbation in the previous 12 months prior to V1;
10. To have a cooperative attitude and the ability to be trained and use correctly the Dry Powder Inhalers (DPI);
11. To have a cooperative attitude and the ability to perform the required outcomes measurements (e.g. spirometry manoeuvres in sitting and supine position) and the ability to understand the risks involved;
12. WOCBP fulfilling one of the following criteria:
a. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or
b. WOCBP with non-fertile male partners (contraception is not required in this case)
13. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile; e.g. amenorrhea for = 12 consecutive months without alternative medical cause).
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Pregnant or lactating woman;
2. Exacerbations defined as a sustained and acute deterioration of subject’s symptoms and signs (dyspnoea, cough and/or sputum production/purulence) that are either moderate, i.e. require treatment with systemic (oral/IV/IM) corticosteroids and/or antibiotics, or severe, i.e. require hospitalization, if their associated treatment/hospitalization occurred within the 30 days before V1 (or 4 weeks in case the event was treated with just systemic corticosteroids) or if the event is recorded during the run-in period;
3. A current asthma diagnosis;
4. Respiratory disorders other than COPD
5. Cardiovascular diseases
6. Evidence or history of other concurrent disease
7. Medical history or current 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;
8. History of lung transplant or lung reduction surgery;
9. ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the subjects at risk. Male subjects with a QTcF >450msec and female subjects with a QTcF > 470msec at V1 are not eligible;
10. Laboratory abnormalities
11. Alcohol/drug abuse
12. Participation to investigational trial: subjects who have received any investigational drug within the 30 days or a more appropriate time as determined by the investigator (e.g. approximately 5 half-lives of the investigational drug, whatever is longer);
13. Contra-indications to IMPs, based on investigator judgement;
14. Hypersensitivity: history of hypersensitivity to any of the study medications components or a history of other allergy that in the opinion of the investigator contraindicates the subject's participation;
15. Subjects mentally or legally incapacitated or subjects accommodated in an establishment as a result of an official or judicial order;
16. Documented COVID-19 diagnosis or its complications which have not resolved within 14 days prior to screening;
17. Positive molecular COVID-19 test within the last 72 hours before the remaining of screening activities.

Study & Design

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