Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma

NCT00557700 | Completed Phase 2

• 1 other identifier: 2007/378
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.

Conditions

Asthma

Keywords

Mild to moderate asthma

Outcome Measures

Primary Outcomes (1)

• The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness

  After 20 days

Secondary Outcomes (2)

• The change in the one-second-value in the forced vital capacity

  After 20 days

• The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness

  After 20 days

Study Arms (2)

2

PLACEBO COMPARATOR

Administration of placebo

Drug: Administration of placebo

1

EXPERIMENTAL

Administration of inhaled tiotropium bromide

Drug: Administration of inhaled tiotropium bromide

Interventions

Administration of inhaled tiotropium bromide DRUG

Administration of inhaled tiotropium bromide

1

Administration of placebo DRUG

Administration of placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Male or female, at least 18 years old
• Documented medical history of asthma (diagnosis at least 6 months ago)
• Non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
• Able to conduct a technically acceptable spirometry, methacholine and neurokinin-A provocation test.
• At visit 1: PC20 methacholine ≤ 8 mg/ml AND ≤ 3.3x10-7 mol/ml for the neurokinin-A provocation test.
• At visit 1: forced expiratory value in one second \>= 80% of the predicted value.
• Female subjects may not get pregnant and should be using adequate contraception.

You may not qualify if:

• Airway infection within 6 weeks prior to first study visit.
• Other respiratory diseases (eg COPD, lung cancer, etc.)
• Participating in another clinical trial.
• Clinically relevant systemic diseases, other than asthma.
• Clinically significant laboratory deviations.
• Alcohol or drug abuse.
• Female subjects who are lactating.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Boehringer Ingelheim: collaborator

Study Sites (2)

University Hospital Ghent

Ghent, 9000, Belgium

Location

CHU Sart Tilman ULG

Liège, 4000, Belgium

Location

Related Links

• Website University Hospital Ghent

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Guy Joos, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 16, 2010

Record last verified: 2010-06

Locations

BE (2)