Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435760
• Other study ID #: M/34273/24
• Secondary ID: 2005-005804-17
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2007
• Last updated: November 16, 2016
• Start date: February 2007
• Est. completion date: August 2007

Study information

• Verified date: November 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

Description:

This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Males and females aged = 40 years

• Current or ex-smokers of = 10 pack-year

• Clinical diagnosis of severe stable COPD

Exclusion Criteria:

• History or current diagnosis of asthma, allergic rhinitis, or atopy

• Respiratory tract infection or acute COPD exacerbation in the last 6 weeks

• Hospitalised for an acute COPD exacerbation in the last 3 months

• Evidence of contraindicated use of anticholinergic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium bromide
200 micrograms, once daily, 1 day treatment
• Placebo Tiotropium
1 puff once daily, 1 day treatment
• Tiotropium
1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00
• Placebo LAS34273
1 puff, 1 dat treatment

Locations

Country	Name	City	State
United Kingdom	Respiratory Clinical Trials Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 Percentage Increase	Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes	30 minutes	No
Secondary	Normalised Area FEV1 AUC 0-3h	Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min	0-3 hours	No

External Links

•   Co-Sponsor web site
•   CSR Synopsis
•   Sponsor web site