Clinical trial NCT02375724: BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
Official title: A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Menarini Group
First posted: 2015-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.


Eligibility criteria: Inclusion Criteria:

1. Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential will follow specific study requirements.
2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
3. Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test available within 6 months prior to Visit 1 (Screening), with FEV1 ≥50% and \<80% and FEV1/FVC \<70%.
4. Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and 2)
5. Clinical Diagnosis of Chronic Bronchitis (defined as "presence of cough and sputum production for at least 3 months in each of 2 consecutive years")
6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained

Exclusion Criteria:

1. History or current diagnosis of asthma.
2. Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period.
3. Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
4. Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
5. Patient who in the investigator's opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
6. Use of long-term oxygen therapy.
7. Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates.
8. Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication.
9. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
10. Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening)
11. Patient with a history of hypersensitivity reaction to inhaled anticholinergics,sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
12. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
13. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
14. Current diagnosis of cancer other than basal or squamous cell skin cancer
15. Patient with any other serious or uncontrolled physical or mental dysfunction
16. Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment.
17. Patient unlikely to be cooperative or that can not comply with the study procedures
18. Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1 (Screening).
19. Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication.
20. Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study.

Primary outcomes:
measure: Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period
timeFrame: Baseline to Week 8
measure: Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Frankfurt/Main
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Luebeck
country: Germany
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Komárom
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Szazhalombatta
country: Hungary
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Hospitalet de Llobregat(Barcel
country: Spain
facility: Research Site
city: Laredo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Santiago(A Coruña)
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Sidcup
country: United Kingdom
facility: Research Site
Study officials:
References: