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

• ClinicalTrials.gov Identifier: NCT02375724
• Recruitment Status: Completed
• First Posted: March 3, 2015
• Results First Posted: April 21, 2017
• Last Update Posted: April 21, 2017
• Sponsor: AstraZeneca
• Collaborator: Menarini Group
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Aclidinium Bromide; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: March 2015
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period [ Time Frame: 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 :

1. Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period [ Time Frame: 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
2. Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8 [ Time Frame: 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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Germany

Research Site

Berlin, Germany

Research Site

Dortmund, Germany

Research Site

Frankfurt/Main, Germany

Research Site

Frankfurt, Germany

Research Site

Hannover, Germany

Research Site

Luebeck, Germany

Hungary

Research Site

Balassagyarmat, Hungary

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Debrecen, Hungary

Research Site

Komárom, Hungary

Research Site

Nyíregyháza, Hungary

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Pécs, Hungary

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Szazhalombatta, Hungary

Italy

Research Site

Napoli, Italy

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Pisa, Italy

Spain

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Alicante, Spain

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Barcelona, Spain

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Hospitalet de Llobregat(Barcel, Spain

Research Site

Laredo, Spain

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Madrid, Spain

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Santiago(A Coruña), Spain

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Sevilla, Spain

United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Northwood, United Kingdom

Research Site

Sidcup, United Kingdom

Sponsors and Collaborators

AstraZeneca

Menarini Group

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02375724
• Other Study ID Numbers: D6560C00001; 2014-004715-37 ( EudraCT Number ); M-34273-46 ( Other Identifier: Clinical Trial Protocol Code )
• First Posted: March 3, 2015
• Results First Posted: April 21, 2017
• Last Update Posted: April 21, 2017
• Last Verified: February 2017

Keywords provided by AstraZeneca:

COPD

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Bromides; Anticonvulsants