A Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

NCT02153489 | Completed Phase 4 Results

• 2 other identifiers: M/34273/472013-003373-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the effect of aclidinium bromide compared with placebo in improving dilatation of the airways (bronchodilation), symptoms of chronic obstructive pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of treatment with aclidinium bromide 400 μg administered twice daily in patients with stable moderate-and-severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment

Other Outcomes (16)

• Change From Baseline in Morning Trough FEV1

  Week 3 of treatment

• Change From Baseline in Peak FEV1

  Week 3 of treatment

• Change From Baseline in Normalized FEV1 AUC0-12hr

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment

Study Arms (2)

Aclidinium bromide

EXPERIMENTAL

Aclidinium bromide 400 μg administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening).

Drug: Aclidinium bromide

Placebo

PLACEBO COMPARATOR

Placebo administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening).

Drug: Placebo

Interventions

Aclidinium bromide DRUG

Also known as: Eklira®

Aclidinium bromide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or non-pregnant, non-lactating female aged ≥40 years. Women of childbearing potential will follow specific study requirements (negative serum pregnancy test at the Screening Visit and are using, over the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control
• Current or ex-cigarette smoker (patients who quit smoking more than 6 months prior to the Screening Visit), with a smoking history of at least 10 pack-years.
• Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD guidelines 2013, with a post bronchodilator FEV1 \<80%, and FEV1 ≥ 40% at Screening Visit
• Patients must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society \[ATS\]/European Respiratory Society \[ERS\] 2005 criteria at Screening Visit
• Patients who are eligible and able to participate in the study and who consents to do so in writing after the purpose and nature of the investigation have been explained

You may not qualify if:

• History or current diagnosis of asthma
• Patients with moderate to severe sleep apnoea assessed at screening
• Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period
• Clinically significant respiratory conditions
• Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
• Patients who may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to the Screening Visit
• Use of long-term oxygen therapy (15 hours/day)
• Patients who does not maintain regular day/night, waking/sleeping cycles including night shift workers
• Clinically significant cardiovascular conditions
• QTc \>470 milliseconds in the manual ECG reading performed at Screening Visit
• Patients with clinically relevant abnormalities in the opinion of the investigator at the Screening Visit (Visit 1) in the results of the clinical laboratory tests, ECG parameters or in the physical examination)
• Patients with a history of hypersensitivity reaction to inhaled anticholinergics, long and short acting β2-agonists, sympathomimetic amines, or inhaled medication or any component there of (including report of paradoxical bronchospasm)
• Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
• Patients with known non-controlled history of human immunodeficiency virus (HIV) infection and/or active hepatitis
• History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Pulmonary Research Institute at the Lung Clinic Grosshansdorf

Großhansdorf, 22927, Germany

Location

Pneumologische Lehrklinik der Universitätsmedizin Göttingen

Immenhausen, 34376, Germany

Location

Related Publications (1)

• Magnussen H, Arzt M, Andreas S, Plate T, Ribera A, Seoane B, Watz H, Kirsten AM. Aclidinium bromide improves symptoms and sleep quality in COPD: a pilot study. Eur Respir J. 2017 Jun 22;49(6):1700485. doi: 10.1183/13993003.00485-2017. Print 2017 Jun. No abstract available.

  PMID: 28642315 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Anna Ribera, PhD

  AstraZeneca Barcelona

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 9, 2016
• Results First Posted: November 9, 2016

Record last verified: 2016-09

Locations

DE (2)