New Version Pulmicort Turbuhaler USA Adults

NCT00642187 | Completed Phase 3

• 2 other identifiers: SD-004-0620D5254C00620
• Study Type: interventional
• Target: 525
• Locations: 0 countries
• Sites: N/A

Brief Summary

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

Conditions

Asthma

Keywords

Asthma; Pulmicort; Turbuhaler; Budesonide; Flexhaler

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Forced Expiratory Volume in 1 second

  Week 2, 4 and 8, then at week 12

Secondary Outcomes (3)

• Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate.

  Week 2, 4 and 8, then at week 12

• Incidence of Adverse Events

  Week 2,4 and 8, then at week 12

• Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration)

  6 or 12 hours post dose

Study Arms (2)

1

EXPERIMENTAL

Pulmicort

Drug: budesonide

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

budesonide DRUG

Also known as: Pulmicort

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
• To enter the run in period, subjects were also required to have the following:
• A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
• At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

You may not qualify if:

• Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
• Use of steroid tablets or injections during the month (28 days) prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
• Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to the study. Subject must not smoke or have smoked within 6 months of the study.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bertil Andersson

  AZ employee

  STUDY DIRECTOR

• Lars-Göran Carlsson

  AZ employee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 24, 2008
• Study Start: July 1, 2002
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: January 24, 2011

Record last verified: 2011-01