| April 23, 2008 |
| November 12, 2009 |
| April 2008 |
| |
| Change from pooled baseline (i.e., post run-in or washout periods) in methacholine airway responsiveness measured as the provocative concentration of methacholine (PC20) that causes a 20% drop in FEV1 for each treatment [ Time Frame: The methacholine challenge test will entail the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 has been reduced by 20%. ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00667992 on ClinicalTrials.gov Archive Site |
- Change from pooled baseline in PEF, FEV1 and Forced Expiratory Flow (FEF25-75) for each treatment [ Time Frame: PEF, FEV1 and Forced Expiratory Flow (FEF25-75) will be measured at each visit from Visit 2 to Visit 7. ] [ Designated as safety issue: No ]
- Change from pooled baseline in exhaled NO for each treatment [ Time Frame: Tidal exhaled nitric oxide (eNO) will be measured at each visit from Visit 2 to Visit 7. ] [ Designated as safety issue: No ]
- Asthma symptom scores (day, night and total) and rescue use consumption (day, night and total) for each treatment. [ Time Frame: Subjects will be asked to record information twice daily onto a paper diary card (Visit 1-7). ] [ Designated as safety issue: No ]
- Change in pooled baseline for morning PEF [ Time Frame: From daily diary ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma |
| A Phase 3, Randomised, Open-label, Crossover Study to Compare HFA vs CFC pMDI Formulations of Budesonide on Methacholine Hyper-reactivity in Patients With Stable, Persistent, Mild to Moderate Asthma |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Asthma |
- Drug: Budesonide HFA
- Drug: Budesonide CFC
|
- Active Comparator: Bud HFA
- Active Comparator: Bud CFC
|
| |
| |
| Completed |
| 60 |
| May 2009 |
|
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
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, United Kingdom |
| |
| NCT00667992 |
| Lars-Göran Carlsson, MD, Medical Science Director, RITA Established Brands Project Team, AstraZeneca Pharmaceuticals |
| D5252C00008 |
| AstraZeneca |
|
| Principal Investigator: |
Brian Lipworth, PhD, MD |
Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee |
|
|
| AstraZeneca |
| November 2009 |
