Asthma Clinical Trial
Official title:
The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | March 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 7 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Teva Pharmaceutical Industries |
Israel,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenosine Challenge Test | Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded | ten weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|