NCT00667992

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3 asthma

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 7, 2012

Completed
Last Updated

November 7, 2012

Status Verified

October 1, 2012

Enrollment Period

1.1 years

First QC Date

April 23, 2008

Results QC Date

May 12, 2010

Last Update Submit

October 9, 2012

Conditions

Asthma

Keywords

Asthma hyperreactivity

Outcome Measures

Primary Outcomes (1)

  • PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)

    Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%. The ratio of Methacholine concentration measured at 2 weeks to that at Baseline.

    Baseline and week 2

Secondary Outcomes (11)

  • Peak Exploratory Flow (PEF)

    Baseline to week 2 recorded daily

  • FEV1 (Forced Expiratory Volume in 1 Second)

    Baseline to week 2

  • FEF 25-75 (Forced Expiratory Flow 25-75)

    Baseline and week 2

  • eNO (Exhaled Nitrogen Oxide)

    baseline and week 2

  • Asthma Symptom Score Morning

    2 weeks

  • +6 more secondary outcomes

Study Arms (4)

Budesonide Hydrofluoroalkane (HFA) 100

ACTIVE COMPARATOR

Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks

Drug: Budesonide HFA

Budesonide HFA 400

ACTIVE COMPARATOR

Budesonide HFA 400 mcg twice daily for 2 weeks

Drug: Budesonide HFA

Budesonide Chlorofluorocarbon (CFC) 100

ACTIVE COMPARATOR

Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks

Drug: Budesonide CFC

Budesonide CFC 400

ACTIVE COMPARATOR

Budesonide CFC 400 mcg twice daily for 2 weeks

Drug: Budesonide CFC

Interventions

Budesonide HFADRUG

standard daily inhaled dose

Budesonide HFA 400Budesonide Hydrofluoroalkane (HFA) 100
Budesonide CFCDRUG

standard daily inhaled dose

Budesonide CFC 400Budesonide Chlorofluorocarbon (CFC) 100

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

King of Prussia, Pennsylvania, United States

Location

Research Site

Dundee, Scotland, United Kingdom

Location

Research Site

Perth, Scotland, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28065396DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Brian Lipworth, PhD, MD

    Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 28, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 7, 2012

Results First Posted

November 7, 2012

Record last verified: 2012-10

Locations

GB(2)US(1)