Clinical trial NCT00667992: Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma hyperreactivity
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)
timeFrame: Baseline and week 2
Secondary outcomes:
measure: Peak Exploratory Flow (PEF)
timeFrame: Baseline to week 2 recorded daily
measure: FEV1 (Forced Expiratory Volume in 1 Second)
timeFrame: Baseline to week 2
measure: FEF 25-75 (Forced Expiratory Flow 25-75)
timeFrame: Baseline and week 2
measure: eNO (Exhaled Nitrogen Oxide)
timeFrame: baseline and week 2
measure: Asthma Symptom Score Morning
timeFrame: 2 weeks
measure: Asthma Symptom Score Evening
timeFrame: 2 weeks
measure: Asthma Symptom Score Total
timeFrame: 2 weeks
measure: Rescue Medication Morning
timeFrame: 2 weeks
measure: Rescue Medication Evening
timeFrame: 2 weeks
measure: Rescue Medication Total
timeFrame: 2 weeks
measure: Peak Exploratory Flow (PEF) Morning
timeFrame: 2 weeks
Other outcomes:
Locations:
city: King of Prussia
country: United States
facility: Research Site
state: Pennsylvania
city: Dundee
country: United Kingdom
facility: Research Site
state: Scotland
city: Perth
country: United Kingdom
facility: Research Site
state: Scotland
Study officials:
affiliation: Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee
name: Brian Lipworth, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.