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Tiotropium for Smoking Asthmatics Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00546234
Recruitment Status : Withdrawn (No subjects enrolled and no ongoing funding.)
First Posted : October 18, 2007
Last Update Posted : May 26, 2016
Information provided by (Responsible Party):
Irvin Mayers, University of Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: tiotropium Drug: long acting beta agonist Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing Treatment Options for Smokers With Asthma.
Study Start Date : November 2007
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Irvin Mayers, Dr., University of Alberta
ClinicalTrials.gov Identifier: NCT00546234     History of Changes
Other Study ID Numbers: 233372
First Posted: October 18, 2007    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: August 2014

Keywords provided by Irvin Mayers, University of Alberta:
Virtual Asthma Clinic

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