NCT01725360

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

4.9 years

First QC Date

November 8, 2012

Last Update Submit

August 4, 2017

Conditions

Asthma

Keywords

asthmaairway hyperresponsiveness

Outcome Measures

Primary Outcomes (1)

  • pd15 mannitol

    Improvement in pd15 mannitol over a treatment period of 4 weeks.

    4 weeks

Secondary Outcomes (1)

  • pd20 methacholine

    4 weeks

Other Outcomes (2)

  • Juniper asthma control questionnaire

    4 weeks

  • exhaled nitric oxide

    4 weeks

Study Arms (1)

montelukast

EXPERIMENTAL

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

Interventions

montelukastDRUG

Adding montelukas to a preexisting treatment with inhaled corticosteroid and long-acting betamimetic in patients with well-controlled asthma.

Also known as: Singulair
montelukast

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically well-controlled asthma

You may not qualify if:

  • Smokers
  • women planning a pregnancy or pregnant
  • patients with any significant illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, CH-3010, Switzerland

Location

Related Publications (1)

  • Kononowa N, Michel S, Miedinger D, Pichler CE, Chhajed PN, Helbling A, Leuppi JD. Effects of add-on montelukast on airway hyperresponsiveness in patients with well-controlled asthma - a pilot study. J Drug Assess. 2013 Apr 2;2(1):49-57. doi: 10.3109/21556660.2013.791300. eCollection 2013.

    PMID: 27536437DERIVED

MeSH Terms

Conditions

AsthmaRespiratory Hypersensitivity

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Arthur Helbling, MD

    University Hospital Bern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 12, 2012

Study Start

January 1, 2007

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

CH(1)