Change of Airway Hyperresponsiveness to Mannitol and Methacholine in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jörg Leuppi, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01725360
First received: November 8, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

Control of airway inflammation is the cornerstone of asthma management. The aim of the present pilot study was to assess whether, and in which magnitude, a leukotriene receptor antagonist (LTRA) added to a basic treatment of inhaled corticosteroids (ICS) + long-acting betamimetics (LABA) might improve airway hyperresponsiveness and inflammation in well-controlled patients with asthma.


Condition Intervention Phase
Asthma
Drug: montelukast
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Change of Airway Hyperresponsiveness to Mannitol and Methacholine During Intensified Anti-inflammatory Treatment in Patients With Asthma.

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • pd15 mannitol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in pd15 mannitol over a treatment period of 4 weeks.


Secondary Outcome Measures:
  • pd20 methacholine [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    change in pd20 methacholine over a treatment period of four weeks.


Other Outcome Measures:
  • Juniper asthma control questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • exhaled nitric oxide [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: January 2007
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: montelukast
A leukotriene receptor antagonist (LTRA, montelukast) is added to a basic treatment of inhaled corticosteroids (ICS) + long-acting betamimetics (LABA) in well-controlled patients with asthma.
Drug: montelukast
Adding montelukas to a preexisting treatment with inhaled corticosteroid and long-acting betamimetic in patients with well-controlled asthma.
Other Name: Singulair

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically well-controlled asthma

Exclusion Criteria:

  • Smokers
  • women planning a pregnancy or pregnant
  • patients with any significant illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725360

Locations
Switzerland
University Hospital Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Arthur Helbling, MD University Hospital Bern Switzerland
  More Information

No publications provided

Responsible Party: Jörg Leuppi, Professor, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01725360     History of Changes
Other Study ID Numbers: KEK-BE 240/06
Study First Received: November 8, 2012
Last Updated: November 9, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
asthma
airway hyperresponsiveness

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mannitol
Methacholine Chloride
Montelukast
Leukotriene Antagonists
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 17, 2014