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Also known as Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate HFA · 2 trials · 4 indications
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
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
| Arm | Type | Description |
|---|---|---|
| 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, |
| Qvar, adenosine challenge test | ACTIVE_COMPARATOR | Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day |
| BDP HFA 80 µg/day | EXPERIMENTAL | During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily. |
| BDP HFA 160 µg/day | EXPERIMENTAL | During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily. |
| BDP HFA 320 µg/day | EXPERIMENTAL | During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. |
| Placebo | PLACEBO_COMPARATOR | During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. |
| Name | Type | Description |
|---|---|---|
| Beclomethasone dipropionate HFA | DRUG | 100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test |
| placebo | DRUG | inhalation twice a day for one month, preceded and followed by adenosine challenge test |
| Beclomethasone dipropionate HFA Nasal Aerosol | DRUG | Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol |
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 ...