Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Summary

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Timeline

Start

2009-10

Primary completion

2010-11

Completion

2010-11

Publications

• McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
• Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
• Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.
• Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.

Drugs

Indications