Phase 3
Completed N=99
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Source: ClinicalTrials.gov NCT00667992 ↗Enrolled (actual)
99
Serious AEs
0.9%
Results posted
Nov 2012
Primary outcomePrimary: PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume) — 1.546; 2.163; 1.673; 2.079 Ratio
Summary
This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume) |
1.546; 2.163; 1.673; 2.079 | — |
| SECONDARY Peak Exploratory Flow (PEF) |
9.7; 12.7; 12.0; 9.1 | — |
| SECONDARY FEV1 (Forced Expiratory Volume in 1 Second) |
0.08; 0.10; 0.10; 0.11 | — |
| SECONDARY FEF 25-75 (Forced Expiratory Flow 25-75) |
0.11; 0.14; 0.15; 0.20 | — |
| SECONDARY eNO (Exhaled Nitrogen Oxide) |
0.66; 0.57; 0.66; 0.59 | — |
| SECONDARY Asthma Symptom Score Morning |
0.39; 0.29; 0.39; 0.30 | — |
| SECONDARY Asthma Symptom Score Evening |
0.48; 0.32; 0.46; 0.36 | — |
| SECONDARY Asthma Symptom Score Total |
0.87; 0.61; 0.85; 0.66 | — |
| SECONDARY Rescue Medication Morning |
0.71; 0.45; 0.62; 0.50 | — |
| SECONDARY Rescue Medication Evening |
0.90; 0.67; 0.84; 0.64 | — |
| SECONDARY Rescue Medication Total |
1.58; 1.10; 1.39; 1.05 | — |
| SECONDARY Peak Exploratory Flow (PEF) Morning |
426; 437; 428; 438 | — |
Eligibility Criteria
Inclusion Criteria
- Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 > 60 %
- ICS taking ≤ 1000 μg BDP per day, or equivalent
- Methacholine PC20 < 4 mg/mL
Exclusion Criteria
- Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
- Currently a smoker or who has ceased smoking within 6 months of Visit 1.
- Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis
Data sourced from ClinicalTrials.gov (NCT00667992). 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.