Phase 4
Completed N=16
Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)
Source: ClinicalTrials.gov NCT00915538 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters. — 2.77; 2.79 Liters X hours — p=0.76
◆ Published Evidence
Emerging
5citations · ~0 / year
A valved holding chamber does not decrease the bronchodilator activity of budesonide-formoterol combination metered dose inhaler.
Summary
This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing in the medication. Breathing tests will be measured over a 12 hour period for the comparison.
Linked Publications
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A valved holding chamber does not decrease the bronchodilator activity of budesonide-formoterol combination metered dose inhaler.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters. |
2.77; 2.79 | 0.76 |
| SECONDARY FEV-1/FVC |
76.13; 75.58; 79.08; 79.91; 78.55; 81.16 | 0.76 |
Eligibility Criteria
Inclusion Criteria
- Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI
Exclusion Criteria
- Any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders Inability to understand and sign informed consent
Data sourced from ClinicalTrials.gov (NCT00915538) and the linked publication. 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.