N/A
Completed N=7
Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Source: ClinicalTrials.gov NCT01111110 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. — -15.4; 26.7 percentage of change from 4AM — p=0.026
Summary
Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. |
-15.4; 26.7 | 0.026 sig |
| PRIMARY Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. |
-15.3; 31.8 | 0.018 sig |
| PRIMARY Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. |
-17.5; 31.9 | 0.013 sig |
Eligibility Criteria
Inclusion Criteria
- Age 18-65 years.
- Physician diagnosis of asthma.
- FEV1 60-80% predicted during the day.
- FEV1 increases ≥ 12 % and to ≥ 80% predicted after 2- 4 puffs of albuterol HFA MDI delivered by antistatic VHC.
- No smoking in the previous year and < 10-pack year history.
- No history of severe asthma attacks requiring ER visit or hospitalization in the previous three months.
Exclusion Criteria
- Patient required a short course of oral steroid in the past 30 days.
- Any disease that is inadequately controlled or any medication that would worsen asthma or interact with asthma medications.
- History of viral respiratory tract infection in the 3 weeks prior to the screening visit.
- Positive pregnancy test.
Data sourced from ClinicalTrials.gov (NCT01111110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.