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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:
Collaborator:
Menarini Group
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02375724
First received: February 26, 2015
Last updated: December 9, 2015
Last verified: December 2015
  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 Blind (Subject, 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 EXACT-Respiratory Symptoms Total score [ Time Frame: From Baseline up to 8 weeks ]
    Change form baseline in Overall EXACT-Respiratory Symptoms up to 8 weeks will be measured


Secondary Outcome Measures:
  • Change from baseline in Overall EXACT-Respiratory Symptoms of Cough and Sputum Domain Score [ Time Frame: From Baseline up to 8 weeks ]
    Change from baseline of Cough and Sputum up to 8 weeks will be measured through a domain score embedded within the EXACT Respiratory Symptoms Questionnaire

  • Change from baseline in the Leicester Cough Questionnaire Total score [ Time Frame: From Baseline up to 8 weeks ]
    Change from baseline in the Leicester Cough Questionnaire up to 8 weeks will be measured


Enrollment: 301
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
8 weeks ±3 days, double blind treatment period
Drug: Aclidinium Bromide
Inhaled Aclidinium 400 μg twice per day
Placebo Comparator: Placebo to Aclidinium Bromide 400 μg
8 weeks ±3 days, double blind treatment period
Drug: Placebo
Inhaled dose-matched placebo, twice per day

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: February 26, 2015
Last Updated: December 9, 2015

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

ClinicalTrials.gov processed this record on March 24, 2017