Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

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AstraZeneca

Status and phase

Completed
Phase 2

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Placebo
Drug: Tiotropium 18 μg once-daily
Drug: Aclidinium bromide 400 μg bid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00868231
M/34273/23

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

Enrollment

30 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 3 patient groups, including a placebo group

Aclidinium 400 μg bid
Experimental group
Description:
Aclidinium bromide 400 μg twice-daily by inhalation
Treatment:
Drug: Aclidinium bromide 400 μg bid
Tiotropium 18 μg once-daily
Active Comparator group
Description:
Tiotropium 18 μg once-daily by inhalation
Treatment:
Drug: Tiotropium 18 μg once-daily
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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