BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: Aclidinium Bromide

Registration Number: NCT02375724

Lead Sponsor: AstraZeneca

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

Inclusion Criteria

Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential will follow specific study requirements.
Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
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%.
Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and 2)
Clinical Diagnosis of Chronic Bronchitis (defined as "presence of cough and sputum production for at least 3 months in each of 2 consecutive years")
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

History or current diagnosis of asthma.
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.
Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
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.
Use of long-term oxygen therapy.
Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates.
Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication.
Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening)
Patient with a history of hypersensitivity reaction to inhaled anticholinergics,sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
Current diagnosis of cancer other than basal or squamous cell skin cancer
Patient with any other serious or uncontrolled physical or mental dysfunction
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.
Patient unlikely to be cooperative or that can not comply with the study procedures
Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1 (Screening).
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.
Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo twice daily by inhalation
Aclidinium Bromide 400 μg	Aclidinium Bromide	Aclidinium Bromide 400 μg twice daily by inhalation

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period	Baseline to Week 8	The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period	Baseline to Week 8	The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8	Week 8	The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life