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Montelukast in Children With Wheezing

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. Identifier: NCT00775697
Recruitment Status : Unknown
Verified June 2013 by Boner Attilio, Universita di Verona.
Recruitment status was:  Enrolling by invitation
First Posted : October 20, 2008
Last Update Posted : June 19, 2013
Azienda Ospedaliera Universitaria Policlinico
Information provided by (Responsible Party):
Boner Attilio, Universita di Verona

Brief Summary:
In this study children with recurrent wheezing (>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.

Condition or disease Intervention/treatment Phase
Wheezing Drug: Montelukast Phase 4

Detailed Description:

Patients aged less than 2 years with recurrent wheezing. At visit 1 patients with symptoms will be enrolled and the study explained. They will return home with bronchodilator therapy.

Within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. Skin prick test will be evaluated at that time.

At visit 3 after 1 week of the run-in period they will start therapy with Montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries.

The final visit will be after four weeks with re-evaluation of the lung function

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years
Study Start Date : September 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Montelukast
the single arm will receive montelukast
Drug: Montelukast
the arm will be treated with Montelukast 4 mg die for 4 weeks
Other Name: antileukotrienes
Drug: Montelukast
montelukast 4 mg day for 4 weeks
Other Name: antileukotrienes

Primary Outcome Measures :
  1. Lung function test (flow and resistance) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Bronchodilator use Dairy symptoms [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 6-24 months
  • Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
  • Patients with symptoms at enrollment

Exclusion Criteria:

  • Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission

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 identifier (NCT number): NCT00775697

Clinica Pediatrica Universita' di Verona Policlinico GB Rossi
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Azienda Ospedaliera Universitaria Policlinico
Principal Investigator: Attilio L Boner, MD Universita di Verona

Responsible Party: Boner Attilio, Prof, Universita di Verona Identifier: NCT00775697     History of Changes
Other Study ID Numbers: AABB1948
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Boner Attilio, Universita di Verona:
lung function

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Leukotriene Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
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