MedDataX Logo

The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children

NCT ID: NCT01006655

Last Updated: 2015-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation.

The investigators' group has reported successfully the possibility to perform Pulmonary Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported relation between asthma control and reduction in airway hyperreactivity. The purpose of this study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways hyperreactivity in preschool children, as demonstrated by adenosine challenge test.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment Beclometasone dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive weeks. Adenosine Challenge test will be performed another time at the end of this four weeks period. After 2 weeks with no medication (wash out period) the patients will receive the second intervention (beclometasone dipropionate or placebo) in a cross over manner and will be submitted to the last adenosine challenge test.

Clinical evaluation, resting spirometry and subjective evaluation through an analogical symptoms scale will be recorded in each visit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Bronchial Hyperresponsiveness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo, adenosine challenge test

Controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test,

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

inhalation twice a day for one month, preceded and followed by adenosine challenge test

Qvar, adenosine challenge test

Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day

Group Type ACTIVE_COMPARATOR

Beclomethasone dipropionate HFA

Intervention Type DRUG

100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beclomethasone dipropionate HFA

100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test

Intervention Type DRUG

placebo

inhalation twice a day for one month, preceded and followed by adenosine challenge test

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Qvar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* clinical diagnosis of mild asthma
* children aged between 3 - 6 years old
* able to perform spirometry and adenosine challenge test
* positive challenge test at the time of inclusion
* without prophylactic treatment for asthma
* signed informed consent to join the research by the parents or legal tutor

Exclusion Criteria

* other chronic diseases
* use of oral steroids in the last two months
* emergency room visit in the last two months
* pneumonia in the last two months
* impossibility to perform lung function tests
* disagreement of the parents or legal tutor
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

l_bentur

Head of pediatric pulmonary institute, Ruth children hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lea Bentur, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam Medical Center

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

Menzies D, Nair A, Hopkinson P, McFarlane L, Lipworth BJ. Differential anti-inflammatory effects of large and small particle size inhaled corticosteroids in asthma. Allergy. 2007 Jun;62(6):661-7. doi: 10.1111/j.1398-9995.2007.01376.x.

Reference Type BACKGROUND
PMID: 17508971 (View on PubMed)

Koh YY, Lee MH, Sun YH, Park Y, Kim CK. Improvement in bronchial hyperresponsiveness with inhaled corticosteroids in children with asthma: importance of family history of bronchial hyperresponsiveness. Am J Respir Crit Care Med. 2002 Aug 1;166(3):340-5. doi: 10.1164/rccm.2101158.

Reference Type BACKGROUND
PMID: 12153967 (View on PubMed)

Hakim F, Vilozni D, Adler A, Livnat G, Tal A, Bentur L. The effect of montelukast on bronchial hyperreactivity in preschool children. Chest. 2007 Jan;131(1):180-6. doi: 10.1378/chest.06-1402.

Reference Type BACKGROUND
PMID: 17218573 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

qvar-adenosineCTIL

Identifier Type: -

Identifier Source: org_study_id