Asthma, Bronchial Hyperresponsiveness
Conditions
Keywords
asthma, preschool children, bronchial hyperresponsiveness, beclometasone dipropionate - HFA, Qvar, Adenosine Challenge test
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.
Detailed description
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.
Interventions
100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test
DRUGplacebo
inhalation twice a day for one month, preceded and followed by adenosine challenge test
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenosine Challenge Test | ten weeks | 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 |
Countries
Israel
Participant flow
Recruitment details
Participants recruited from Pediatric pulmonology out clinic, Rambam Medical Center, Haifa, Israel between March 2009 and January 2010
Pre-assignment details
40 participants approached, 23 agreed and have been screened, 2 excluded (1 adenosine challenge test negative, 1 obstructive respiratory impairment)
Participants by arm
| Arm | Count |
|---|---|
| Placebo First, Adenosine Challenge Test 11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test | 11 |
| Qvar First, Adenosine Challenge Test 10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test | 10 |
| Total | 21 |
Baseline characteristics
| Characteristic | Qvar First, Adenosine Challenge Test | Placebo First, Adenosine Challenge Test | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.05 years STANDARD_DEVIATION 1.05 | 4.94 years STANDARD_DEVIATION 1.08 | 4.95 years STANDARD_DEVIATION 1.05 |
| Region of Enrollment Israel | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
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
Time frame: ten weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo First, Adenosine Challenge Test | Adenosine Challenge Test | 18.46 mg/ml | Standard Deviation 26.17 |
| Qvar First, Adenosine Challenge Test | Adenosine Challenge Test | 142.61 mg/ml | Standard Deviation 71.6 |