Tiotropium for Smoking Asthmatics Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Irvin Mayers, University of Alberta
ClinicalTrials.gov Identifier:
NCT00546234
First received: October 16, 2007
Last updated: June 4, 2013
Last verified: June 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing Treatment Options for Smokers With Asthma.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • To determine if the Virtual Asthma Clinic is an acceptable tool for data collection in a clinical trial setting. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: tiotropium
18 mcg daily via Handihaler
Other Name: Spiriva
Active Comparator: 2 Drug: long acting beta agonist
Turbohaler, 6 & 12 mcg
Other Names:
  • Serevent
  • Oxeze

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Angie Hillaby (780) 407-2972 ahillaby@ualberta.ca
Contact: Fiona Luke (780) 407-2972 fiona.luke@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
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

Responsible Party: Irvin Mayers, Dr., University of Alberta
ClinicalTrials.gov Identifier: NCT00546234     History of Changes
Other Study ID Numbers: 233372
Study First Received: October 16, 2007
Last Updated: June 4, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Alberta:
asthma
tiotropium
smoking
eNO
metabolites
Virtual Asthma Clinic

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014