Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tiotropium for Smoking Asthmatics Study

This study has been withdrawn prior to enrollment.
(No subjects enrolled and no ongoing funding.)
Information provided by (Responsible Party):
Irvin Mayers, University of Alberta Identifier:
First received: October 16, 2007
Last updated: August 26, 2014
Last verified: August 2014

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
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 ]

Enrollment: 0
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


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

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 identifier: NCT00546234

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
University of Alberta
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 Identifier: NCT00546234     History of Changes
Other Study ID Numbers: 233372
Study First Received: October 16, 2007
Last Updated: August 26, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Alberta:
Virtual Asthma Clinic

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on November 20, 2014