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

NCT01006655 | Completed Phase 2 Results

• 1 other identifier: qvar-adenosineCTIL
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Bronchial Hyperresponsiveness

Keywords

asthma; preschool children; bronchial hyperresponsiveness; beclometasone dipropionate - HFA; Qvar; Adenosine Challenge test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

placebo, adenosine challenge test

PLACEBO COMPARATOR

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

Drug: placebo

Qvar, adenosine challenge test

ACTIVE COMPARATOR

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

Drug: Beclomethasone dipropionate HFA

Interventions

Beclomethasone dipropionate HFA DRUG

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

Also known as: Qvar

Qvar, adenosine challenge test

placebo DRUG

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

placebo, adenosine challenge test

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Related Publications (3)

• 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.

  PMID: 17508971 BACKGROUND

• 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.

  PMID: 12153967 BACKGROUND

• 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.

  PMID: 17218573 BACKGROUND

MeSH Terms

Conditions

Asthma; Bronchial Hyperreactivity

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Results Point of Contact

• Title: Prof Lea Bentur
• Organization: Rambam medical Center

l_bentur@rambam.health.gov.il

xx 972 4 854 3263

Study Officials

• Lea Bentur, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pediatric pulmonary institute, Ruth children hospital

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 24, 2015
• Results First Posted: August 31, 2010

Record last verified: 2015-10

Locations

IL (1)