The Impact of Dosimeter on Measurement of Airway Responsiveness to Methacholine

NCT00145990 | Completed

• 1 other identifier: 257-2005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether there is a difference in two different breathing tests used to detect asthma. Hypothesis: The Digidoser delivers less methacholine to the airways and will result in a higher PC20 than the value determined by the Rosenthal Dosimeter.

Conditions

Asthma

Keywords

methacholine PC20; dosimeter; asthma

Outcome Measures

Primary Outcomes (1)

• Geometric mean PC20 methacholine for each dosimeter method.

Interventions

methacholine DRUG

KoKo Digidoser DEVICE

Rosethal Dosimeter DEVICE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking male or female \>18 years of age, with a previous diagnosis of asthma.
• Women of child bearing age must not be pregnant or nursing and be using an acceptable method of contraception.
• Screening FEV1 \> 70% of predicted for height, age, sex, and race when bronchodilators are withheld for appropriate intervals.
• At least a 20% decrease in FEV1 after inhaling ≤ 8 mg/ml of methacholine (i.e., a PC20 FEV1 ≤8 mg/ml) using the KoKo Digidoser system.
• Ability to perform ATS-acceptable and reproducible spirometry.

You may not qualify if:

• Cigarette smoking in past year or \> 10 pack year smoking history.
• Respiratory tract infection within the last four weeks.
• History of severe asthma attack requiring hospitalization in the previous 12 months.
• Short course of oral corticosteroids in the past 3 weeks.
• Inability to withhold caffeinated beverages for 12 hours or medications for appropriate intervals prior to each methacholine challenge.
• If female, a positive urine β-HCG test.

Sponsors & Collaborators

• University of Florida: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Florida Asthma Research Lab

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Methacholine Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Yasmeen Khan, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

US (1)