Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

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AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Aclidinium bromide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00970268
LAS-MD-36

Details and patient eligibility

About

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Enrollment

291 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completion of a lead-in study (NCT00891462)

Exclusion criteria

  • Use or anticipated use of any medication prohibited in this study
  • Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
  • The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
  • QTcB of >500 msec on both the pre-dose and post-dose ECG
  • Women who are pregnant, intend to become pregnant, or are breast-feeding
  • A life expectancy of less than 1 year
  • Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
  • Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

291 participants in 2 patient groups

1
Experimental group
Description:
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Treatment:
Drug: Aclidinium bromide
2
Experimental group
Description:
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Treatment:
Drug: Aclidinium bromide

Trial contacts and locations

83

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Data sourced from clinicaltrials.gov

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