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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02375724
First Posted: March 3, 2015
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Menarini Group
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Aclidinium Bromide Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

  • 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


Enrollment: 300
Study Start Date: March 2015
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 110 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375724


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
Research Site
Debrecen, Hungary
Research Site
Komárom, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Pécs, Hungary
Research Site
Szazhalombatta, Hungary
Italy
Research Site
Napoli, Italy
Research Site
Pisa, Italy
Spain
Research Site
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
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     History of Changes
Other Study ID Numbers: D6560C00001
2014-004715-37 ( EudraCT Number )
M-34273-46 ( Other Identifier: Clinical Trial Protocol Code )
First Submitted: February 26, 2015
First Posted: March 3, 2015
Results First Submitted: October 27, 2016
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:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Bromides
Anticonvulsants