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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725360
First Posted: November 12, 2012
Last Update Posted: August 7, 2017
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.
Information provided by (Responsible Party):
Prof. Dr. Jörg Leuppi, University Hospital, Basel, Switzerland
  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: Intervention Model: Single Group Assignment
Masking: None (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 Prof. Dr. Jörg Leuppi, University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • pd15 mannitol [ Time Frame: 4 weeks ]
    Improvement in pd15 mannitol over a treatment period of 4 weeks.


Secondary Outcome Measures:
  • pd20 methacholine [ Time Frame: 4 weeks ]
    change in pd20 methacholine over a treatment period of four weeks.


Other Outcome Measures:
  • Juniper asthma control questionnaire [ Time Frame: 4 weeks ]
  • exhaled nitric oxide [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01725360


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Jörg Leuppi, Prof. Dr., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01725360     History of Changes
Other Study ID Numbers: KEK-BE 240/06
First Submitted: November 8, 2012
First Posted: November 12, 2012
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by Prof. Dr. Jörg Leuppi, University Hospital, Basel, Switzerland:
asthma
airway hyperresponsiveness

Additional relevant MeSH terms:
Asthma
Respiratory Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Methacholine Chloride
Mannitol
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics
Bronchoconstrictor Agents
Muscarinic Agonists