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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00435760

First received: February 14, 2007

Last updated: November 16, 2016

Last verified: November 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2007

Last Updated Date

November 16, 2016

Start Date ^ICMJE

February 2007

Primary Completion Date

August 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

FEV1 Percentage Increase [ Time Frame: 30 minutes ]

Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00435760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Normalised Area FEV1 AUC 0-3h [ Time Frame: 0-3 hours ]

Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Brief 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.

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

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

Study Arms

Active Comparator: Tiotropium
1 puff, 1 day treatment

Intervention: Drug: Tiotropium
Placebo Comparator: Placebo
Tiotropium or Aclidinium Placebo, 1 day treatment
Interventions:
- Drug: Placebo Tiotropium
- Drug: Placebo LAS34273
Experimental: Aclidinium bromide
200 micrograms, once daily, 1 day treatment

Intervention: Drug: Aclidinium bromide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

115

Completion Date

August 2007

Primary Completion Date

August 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

40 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00435760

Other Study ID Numbers ^ICMJE

M/34273/24
2005-005804-17 ( EudraCT Number )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Esther Garcia, MD

AstraZeneca

PRS Account

AstraZeneca

Verification Date

November 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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