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

NCT02375724 | Completed Phase 4 Results

• 3 other identifiers: D6560C000012014-004715-37M-34273-46
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 24

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period

  Baseline to Week 8

• Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8

  Week 8

Study Arms (2)

Aclidinium Bromide 400 μg

EXPERIMENTAL

Aclidinium Bromide 400 μg twice daily by inhalation

Drug: Aclidinium Bromide

Placebo

PLACEBO COMPARATOR

placebo twice daily by inhalation

Drug: Placebo

Interventions

Aclidinium Bromide DRUG

Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler

Aclidinium Bromide 400 μg

Placebo DRUG

Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler

Placebo

Eligibility Criteria

• Age: 40 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Menarini Group: collaborator

Study Sites (24)

Research Site

Berlin, Germany

Location

Research Site

Dortmund, Germany

Location

Research Site

Frankfurt, Germany

Location

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Frankfurt am Main, Germany

Location

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Hanover, Germany

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Lübeck, Germany

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Research Site

Balassagyarmat, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Komárom, Hungary

Location

Research Site

Nyíregyháza, Hungary

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Research Site

Pécs, Hungary

Location

Research Site

Százhalombatta, Hungary

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Napoli, Italy

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Research Site

Pisa, Italy

Location

Research Site

Alicante, Spain

Location

Research Site

Barcelona, Spain

Location

Research Site

Hospitalet de Llobregat(Barcel, Spain

Location

Research Site

Laredo, Spain

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Research Site

Madrid, Spain

Location

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Santiago(A Coruña), Spain

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Seville, Spain

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Manchester, United Kingdom

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Research Site

Northwood, United Kingdom

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Research Site

Sidcup, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-02

Locations

DE (6); ES (7); HU (6); IT (2); GB (3)