BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
NCT ID: NCT02375724
Last Updated: 2017-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2015-03-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aclidinium Bromide 400 μg
Aclidinium Bromide 400 μg twice daily by inhalation
Aclidinium Bromide
Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler
Placebo
placebo twice daily by inhalation
Placebo
Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
Interventions
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Aclidinium Bromide
Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler
Placebo
Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
110 Years
ALL
No
Sponsors
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Menarini Group
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Berlin, , Germany
Research Site
Dortmund, , Germany
Research Site
Frankfurt, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Hanover, , Germany
Research Site
Lübeck, , Germany
Research Site
Balassagyarmat, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Komárom, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Pécs, , Hungary
Research Site
Százhalombatta, , Hungary
Research Site
Napoli, , Italy
Research Site
Pisa, , Italy
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
Seville, , Spain
Research Site
Manchester, , United Kingdom
Research Site
Northwood, , United Kingdom
Research Site
Sidcup, , United Kingdom
Countries
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Other Identifiers
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2014-004715-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M-34273-46
Identifier Type: OTHER
Identifier Source: secondary_id
D6560C00001
Identifier Type: -
Identifier Source: org_study_id
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