Tiotropium for Smoking Asthmatics Study

This study is currently recruiting participants.

Verified by University of Alberta, January 2009

First Received: October 16, 2007 Last Updated: January 9, 2009 History of Changes

Sponsors and Collaborators:	University of Alberta Boehringer Ingelheim Pharmaceuticals
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00546234

Purpose

The study's research questions concern the appropriateness of use of tiotropium for patients with asthma who are current smokers. It is suggested that patients with asthma who smoke, may in fact share similarities with patients with chronic obstructive pulmonary disease (COPD). Because of this, the study will determine whether this sub-group of patients would in fact benefit from therapy currently approved and marketed for COPD patients.

Condition	Intervention	Phase
Asthma	Drug: tiotropium Drug: long acting beta agonist	Phase IV

MedlinePlus related topics: Asthma Smoking

Drug Information available for: Tiotropium bromide Tiotropium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Assessing Treatment Options for Smokers With Asthma.

Further study details as provided by University of Alberta:

Primary Outcome Measures:

To evaluate whether current smokers with asthma benefit from the introduction of tiotropium. [ Time Frame: 10 weeks ]

Secondary Outcome Measures:

To assess whether there are specific genotypes that identify specific asthma patient populations that may benefit from this therapy. [ Time Frame: 10 weeks ]
To determine if the Virtual Asthma Clinic is an acceptable tool for data collection in a clinical trial setting. [ Time Frame: 10 weeks ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: tiotropium 18 mcg daily via Handihaler
2: Active Comparator	Drug: long acting beta agonist

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patient with a working diagnosis of asthma by clinical presentation or by spirometry testing results.
Currently prescribed inhaled corticosteroids (ICS) for the treatment of asthma, and may or may not be prescribed additional therapies for asthma.
Is a current smoker with a minimum of a five year history of smoking.
Provides written informed consent.

Exclusion Criteria:

Has a diagnosis of COPD.
Is currently enrolled in another clinical trial.
Has any condition which, may decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
Is unable to provide written informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546234

Contacts

Contact: Denise Reid	(780) 407-2972	denise.reid@ualberta.ca
Contact: Heidi Cheung	(780) 407-2972	heidi.cheung@ualberta.ca

Locations

Canada, Alberta
University of Alberta Hospital	Recruiting
Edmonton, Alberta, Canada
Canada, Saskatchewan
Royal University Hospital	Not yet recruiting
Saskatoon, Saskatchewan, Canada

Sponsors and Collaborators

University of Alberta

Boehringer Ingelheim Pharmaceuticals

Investigators

Principal Investigator:	Irvin Mayers, MD, FRCPC	University of Alberta
Principal Investigator:	Darcy Marciniuk, MD	University of Saskatchewan
Principal Investigator:	Dilini Vethanayagam, MD	University of Alberta
Principal Investigator:	Harissios Vliagoftis, MD	Unviersity of Alberta

More Information

No publications provided

Study ID Numbers:	233372
Study First Received:	October 16, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00546234 History of Changes
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by University of Alberta:

asthma
tiotropium
smoking

eNO
metabolites
Virtual Asthma Clinic

Study placed in the following topic categories:

Neurotransmitter Agents
Salmeterol
Bronchial Diseases
Cholinergic Antagonists
Anti-Asthmatic Agents
Asthma
Cholinergic Agents
Smoking
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Cholinergic Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009