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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— M-34273-46  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375724
• Other study ID #: D6560C00001
• Secondary ID: 2014-004715-37M-
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2015
• Last updated: December 9, 2015
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesItaly: AIFA - Agenzia Italiana del FarmacoSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 110 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium Bromide
Inhaled Aclidinium 400 µg twice per day
• Placebo
Inhaled dose-matched placebo, twice per day

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Germany	Research Site	Dortmund
Germany	Research Site	Frankfurt
Germany	Research Site	Frankfurt/Main
Germany	Research Site	Hannover
Germany	Research Site	Luebeck
Hungary	Research Site	Balassagyarmat
Hungary	Research Site	Debrecen
Hungary	Research Site	Komárom
Hungary	Research Site	Nyíregyháza
Hungary	Research Site	Pécs
Hungary	Research Site	Szazhalombatta
Italy	Research Site	Napoli
Italy	Research Site	Pisa
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
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Sidcup

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Menarini Group

Countries where clinical trial is conducted

Germany,  Hungary,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Overall EXACT-Respiratory Symptoms Total score	Change form baseline in Overall EXACT-Respiratory Symptoms up to 8 weeks will be measured	From Baseline up to 8 weeks	No
Secondary	Change from baseline in Overall EXACT-Respiratory Symptoms of Cough and Sputum Domain Score	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	From Baseline up to 8 weeks	No
Secondary	Change from baseline in the Leicester Cough Questionnaire Total score	Change from baseline in the Leicester Cough Questionnaire up to 8 weeks will be measured	From Baseline up to 8 weeks	No