Tiotropium for Smoking Asthmatics Study

NCT00546234 | Withdrawn Phase 4

• 1 other identifier: 233372
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

asthma; tiotropium; smoking; eNO; metabolites; Virtual Asthma Clinic

Outcome Measures

Primary Outcomes (1)

• To evaluate whether current smokers with asthma benefit from the introduction of tiotropium.

  10 weeks

Secondary Outcomes (2)

• To assess whether there are specific genotypes that identify specific asthma patient populations that may benefit from this therapy.

  10 weeks

• To determine if the Virtual Asthma Clinic is an acceptable tool for data collection in a clinical trial setting.

  10 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: tiotropium

2

ACTIVE COMPARATOR

Drug: long acting beta agonist

Interventions

tiotropium DRUG

18 mcg daily via Handihaler

Also known as: Spiriva

1

long acting beta agonist DRUG

Turbohaler, 6 \& 12 mcg

Also known as: Serevent, Oxeze

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Asthma; Smoking

Interventions

Tiotropium Bromide; Salmeterol Xinafoate; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 18, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 26, 2016

Record last verified: 2014-08

Locations

CA (2)