Research study to evaluate the effect of different doses of inhaled glycopyrronium bromide via Nexthaler in COPD patients

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 18.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000558-40-HU
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-29
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Male or female patients aged = 40 years at screening visit, who have signed an Informed
Consent form prior to initiation of any study-related procedure.
2. Patients with a diagnosis of COPD (according to GOLD guidelines 2015) at least 12
months before screening visit.
3. Current smoker or ex-smoker with a smoking history of at least 10 pack-years defined as
[(number of cigarettes smoked per day) × (number of years of smoking)] / 20.
(If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to
the screening visit. Smoking cessation must be at least 3 months prior the screening. In both
cases the smoking status should not change between the subjects screening visit and subjects last study visit).
4. A post-bronchodilator FEV1 = 40% and =70% of the predicted normal value (measured 30 to 45 minutes after administration of 80 µg ipratropium pMDI) and,
- a post-bronchodilator FEV1/FVC < 0.7 and,
- a change in FEV1 from the pre-bronchodilator value (reversibility) of at least 5% at
screening
If the criterion is not met at screening, the test can be rescheduled once before randomisation.
5. Patients under bronchodilators with long-acting muscarinic antagonist or long-acting
beta-2 agonist (monotherapy or dual therapy), or patients under ICS + LABA or ICS + LAMA for at least 4 weeks prior to screening. (Patients with a FEV1<50% of the predicted value and a history of 1 exacerbation whithin the last 12 months must have been treated with ICS+LABA or ICS+LAMA before screening)
6. Ability and cooperative attitude to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres) and ability to understand the risks involved.
Ability to be trained to use the DPI inhalers.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere
with data interpretation according to the investigator’s opinion.
2. Patients had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids, or hospitalisation.
3. Patients with a history of = 2 exacerbations within the last 12 months prior to screening
(frequent exacerbators).
4. Patients treated with oral/parenteral ß2-agonists or nebulised bronchodilators or PDE
inhibitors or who received LABA/LAMA/ICS treatment therapy in the 4 weeks prior to
screening and during the run-in period.
5. Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period (patients on stable dose of ICS for at least 4 weeks prior to screening are allowed).
6. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
7. Patients with known respiratory disorders other than COPD.
8. Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic.
9. Patients who have unstable concurrent disease, that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study;
10. Patients who have a concomitant disease of poor prognosis
11. Patients who have clinically significant cardiovascular condition
12. Patients with known atrial fibrillation (AF):
a. Paroxysmal Atrial Fibrillation
b. Persistent: AF episode lasting more than 7 days or requiring termination by
cardioversion, either with drugs or by direct current cardioversion (DCC) within 6 months prior to screening visit.
c. Long standing persistent: continuous atrial fibrillation diagnosed for less than 6 months
and/ or without a rhythm control strategy.
d. Permanent: AF diagnosed for at least 6 months with a resting ventricular rate = 100/min
not controlled with a rate control strategy (i.e., selective ß-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy).
13. Patients have a clinically significant abnormal 12-lead ECG that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
14. Patients whose electrocardiogram 12-lead ECG shows a QTcF>450 ms for males or QTcF > 470 ms for females.
15. Patients with clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
16. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control methods such as :
a. Placement of an intrauterine device or intrauterine releasing system
b. Oral, intravaginal, transdermal combined estrogen and progestogen containing hormonal contraception or oral, injectable, implantable progestogen only hormonal
contraception.
c. Bilateral tubal occlusion
d. Partner vasectomy (provided that partner is the sole sexual partner of the WOCBP
tria

Study & Design

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