A clinical study to evaluate the efficacy of a drug (CHF 5993) comparing the results obtained with two different pharmaceutical forms and the effects produced by another drug (CHF 1535), in patients with chronic obstructive pulmonary disease

Phase 1

Conditions: chronic obstructive pulmonary disease (COPD)
MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2017-004405-41-DE

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 506

Inclusion Criteria

1.Age & Informed consent: Male and female adults (40 = age = 85 years) with written informed consent obtained prior to any study-related procedure.
2.COPD Diagnosis: Established diagnosis of COPD (according to GOLD document updated 2017) at least 12 months prior to screening.
3.A Post-bronchodilator FEV1 =30% and <80% of the predicted normal value and FEV1/FVC < 0.7.
Post-bronchodilator test will be measured 10-15 min after the administration of 400µg salbutamol (4 puffs x100µg).
4.A smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20]. Current and ex-smokers are eligible.
5.Previous medication: Patients’ COPD therapy at screening with either:
-Inhaled corticosteroids/long-acting ß2-agonist/long-acting muscarinic antagonist (free or fixed) combination
-Inhaled corticosteroids/long-acting ß2-agonist (free or fixed) combination
-Inhaled long-acting ß2-agonist/long-acting muscarinic antagonist (free or fixed) combination
-Inhaled long-acting muscarinic antagonist alone
if taken at stable regimen at least 30 days before screening
6.Ability to comply with the protocol
7.Ability to use the inhaler

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 253
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 253

Exclusion Criteria

1.Pregnancy and lactation: Pregnant or lactating women and women of childbearing potential with fertile male partners UNLESS they and/or their partner are willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up contact. Being of non-childbearing potential is defined as meeting, at least, one of the following criteria:
•at least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile
•previous surgical sterilization.
2.Diagnosis of asthma: Patients with a current clinical diagnosis of asthma.
3.Respiratory disorders other than COPD that would affect efficacy and safety evaluation or place the patient at risk. This can include but is not limited to known: alpha 1-antitrypsine deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
4.Lung cancer or history of lung cancer: Patients with a diagnosis of lung cancer or a history of lung cancer
5.Cancer or history of cancer (other than lung): Patients with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localised carcinoma (e.g. basal cell carcinoma, in situ carcinoma of the cervix adequately treated,..) is acceptable
6.Lung resection: Patients with a history of lung volume resection.
7.Lower tract respiratory infection that required use of antibiotics within 6 weeks prior to screening or during the run-in period.
8.History of exacerbations: Patients with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic corticosteroids (oral/IV/IM) and/or antibiotics and/or need for hospitalisation] within 6 weeks prior to screening or during the run-in period.
9.Oxygen therapy: Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
10.Patients participating to a pulmonary rehabilitation programme or completing such a programme within 6 weeks prior to screening.
11.Cardiovascular diseases: Patients who have clinically significant cardiovascular condition
12.Atrial Fibrillation (AF)
13.ECG criteria: Any clinically significant abnormal 12-lead ECG that would affect efficacy or safety evaluation or place the patients at risk.
14.Concurrent diseases: Patients with medical history or current diagnosis of narrow-angle glaucoma, symptomatic prostatic hypertrophy, urinary retention or bladder neck obstruction that would prevent use of anticholinergic agents
15.Other concurrent diseases: Patients with historical or current evidence of uncontrolled concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease; haematological disease; autoimmune disorders (e.g. rheumatoid arthritis); significant renal impairment or other diseases / conditions that might place the patient at undue risk or potentially compromise the results or interpretation of the study.
16.Laboratory abnormalities: Patients with clinically significant laboratory abnormalities indicating a significant unstable concomitant disease
17.Patients with hyp

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method