Voriconazole For Chronic Bronchopulmonary Aspergillosis

NCT00159822 | Completed Phase 2 Results

• 1 other identifier: A1501061
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 18

Brief Summary

To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary

Conditions

Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis

  Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.

  at 6 months of treatment

Secondary Outcomes (11)

• Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis

  Month 3 and End of Treatment (Month 9 or Month 12)

• Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis

  at 6 months of treatment

• Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma

  at 6 months of treatment

• Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)

  Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months)

• Number of Subjects With Relapse

  During the 6 months following EOT (EOT + 3 months, EOT + 6 months)

Study Arms (1)

1

EXPERIMENTAL

Drug: Voriconazole

Interventions

Voriconazole DRUG

Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response. Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours

1

Eligibility Criteria

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

You may qualify if:

• Patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest imagery (CT scan) and/or an endoscopic lesion sourced by photo, would it be:
• Complex aspergilloma non primarily operable,
• Chronic necrotizing pulmonary aspergillosis,
• Tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous.

You may not qualify if:

• Patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by medication known to prolong QT interval, or prolongation of QTc interval \> 450 msec in men and \> 470 msec in women.
• Simple aspergilloma with primary indication of surgical treatment.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Pfizer Investigational Site

Nantes, Cedex, 44093, France

Location

Pfizer Investigational Site

Angers, 49033, France

Location

Pfizer Investigational Site

Bobigny, 93000, France

Location

Pfizer Investigational Site

Brest, 29609, France

Location

Pfizer Investigational Site

Bris Sous Forges, 94640, France

Location

Pfizer Investigational Site

Caen, 14033, France

Location

Pfizer Investigational Site

Dinan, 22101, France

Location

Pfizer Investigational Site

Grenoble, 38043, France

Location

Pfizer Investigational Site

Lille, 59037, France

Location

Pfizer Investigational Site

Lyon, 69394, France

Location

Pfizer Investigational Site

Montpellier, 34295, France

Location

Pfizer Investigational Site

Paris, 75010, France

Location

Pfizer Investigational Site

Paris, 75877, France

Location

Pfizer Investigational Site

Paris, 75970, France

Location

Pfizer Investigational Site

Poitiers, 86021, France

Location

Pfizer Investigational Site

Reims, 51092, France

Location

Pfizer Investigational Site

Rouen, 76031, France

Location

Pfizer Investigational Site

Suresnes, 92150, France

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Aspergillosis

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study treatment duration is at least 6 months for subjects with best achievable response after 3 months of treatment, of 9 months for subjects with best achievable response after 6 months of treatment and of 12 months in other cases.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 20, 2010
• Results First Posted: January 7, 2010

Record last verified: 2010-01

Locations

FR (18)