BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH (M-34273-46)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Aclidinium Bromide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Research Site
  • Dortmund, Germany
    • Research Site
  • Frankfurt, Germany
    • Research Site
  • Frankfurt/Main, Germany
    • Research Site
  • Hannover, Germany
    • Research Site
  • Luebeck, Germany
    • Research Site
• Hungary
  • Balassagyarmat, Hungary
    • Research Site
  • Debrecen, Hungary
    • Research Site
  • Komárom, Hungary
    • Research Site
  • Nyíregyháza, Hungary
    • Research Site
  • Pécs, Hungary
    • Research Site
  • Szazhalombatta, Hungary
    • Research Site
• Italy
  • Napoli, Italy
    • Research Site
  • Pisa, Italy
    • Research Site
• Spain
  • Alicante, Spain
    • Research Site
  • Barcelona, Spain
    • Research Site
  • Hospitalet de Llobregat(Barcel, Spain
    • Research Site
  • Laredo, Spain
    • Research Site
  • Madrid, Spain
    • Research Site
  • Santiago(A Coruña), Spain
    • Research Site
  • Sevilla, Spain
    • Research Site
• United Kingdom
  • Manchester, United Kingdom
    • Research Site
  • Northwood, United Kingdom
    • Research Site
  • Sidcup, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aclidinium Bromide 400 μg; Aclidinium Bromide 400 μg twice daily by inhalation	Drug: Aclidinium Bromide; Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler
Placebo Comparator: Placebo; placebo twice daily by inhalation	Drug: Placebo; Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period	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	Baseline to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period	The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms	Baseline to Week 8
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at 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	Week 8

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Menarini Group

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anticonvulsants; Bromides
• Other Study ID Numbers: D6560C00001; 2014-004715-37 (EudraCT Number); M-34273-46 (Other Identifier: Clinical Trial Protocol Code)