CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Beclomethasone dipropionate HFA +1 moredrug
Likely dose
Beclomethasone dipropionate HFA 100µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01006655
NCT01006655Phase 2Completed

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

Rambam Health Care Campus·interventional·Posted Nov 3, 2009·Updated Nov 24, 2015

In Brief

A Phase 2 clinical trial evaluating Beclomethasone dipropionate HFA and placebo for Asthma and Bronchial Hyperresponsiveness. Completed, enrolled 21 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2009
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.7 years ago

Interventions

Beclomethasone dipropionate HFAdrug

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

placebodrug

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