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

• ClinicalTrials.gov Identifier: NCT01001494
• Recruitment Status: Completed
• First Posted: October 26, 2009
• Results First Posted: September 17, 2012
• Last Update Posted: January 4, 2017
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: October 22, 2009
• First Posted Date: October 26, 2009
• Results First Submitted Date: August 14, 2012
• Results First Posted Date: September 17, 2012
• Last Update Posted Date: January 4, 2017
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 2, 2015)

• Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment [ Time Frame: Baseline and Week 12 ]

• Original Primary Outcome Measures (submitted: October 23, 2009): Change from baseline in morning pre-dose (through) Forced Expiratory Volume in the first second (FEV1) [ Time Frame: week 12 and 24 ]

Current Secondary Outcome Measures (submitted: July 2, 2015)

• Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment [ Time Frame: Baseline and Week 24 ]
• Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment [ Time Frame: Week 24 ]
  Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment
• Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment [ Time Frame: Week 24 ]
  Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment

Original Secondary Outcome Measures (submitted: October 23, 2009)

• Change from baseline in peak FEV1 [ Time Frame: week 12 and 24 ]
• Number (%) of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score [ Time Frame: week 24 ]
• Number (%) of patients achieving a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score [ Time Frame: week 24 ]
• Adverse Events, laboratory, Electrocardiogram and vital signs [ Time Frame: week 4, 12 and 24 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
• Official Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease (COPD)

Intervention

• Drug: Aclidinium bromide 200 μg bid
  Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
• Drug: Aclidinium bromide 400 μg bid
  Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
• Drug: Placebo
  Placebo twice-daily by inhalation for 24 weeks

Study Arms

• Experimental: Aclidinium bromide 200 μg bid
  Aclidinium bromide 200 μg twice-daily via inhalation
  Intervention: Drug: Aclidinium bromide 200 μg bid
• Experimental: Aclidininum bromide 400 μg bid
  Aclidinium bromide 400 μg twice-daily via inhalation
  Intervention: Drug: Aclidinium bromide 400 μg bid
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 29, 2012): 828
• Original Estimated Enrollment (submitted: October 23, 2009): 810
• Actual Study Completion Date: November 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
• Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
• Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

• Patients with no history or current diagnosis of asthma.
• No evidence of an exacerbation within 6 weeks prior to the screening visit.
• No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
• No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czech Republic, France, Germany, Hungary, Italy, Peru, Poland, Russian Federation, South Africa, Spain, Ukraine
• Removed Location Countries: Argentina, Chile, Mexico, United Kingdom

Administrative Information

• NCT Number: NCT01001494
• Other Study ID Numbers: M/34273/34; ATTAIN
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: AstraZeneca
• Original Responsible Party: Estrella Garcia, Almirall S.A.
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Almirall, S.A.
• Collaborators: Not Provided

Investigators

• Study Director: Esther Garcia, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: October 2016