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Trial record 21 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

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ClinicalTrials.gov Identifier: NCT00787917
Recruitment Status : Terminated
First Posted : November 10, 2008
Results First Posted : August 4, 2011
Last Update Posted : September 26, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis
Interventions Drug: Omalizumab
Drug: Placebo
Drug: Itraconazole
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description

Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Period Title: Blinded Treatment
Started 9 5
Completed 4 3
Not Completed 5 2
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             1             0
Administrative problems             3             2
Period Title: Open Label
Started 7 0 [1]
Completed 3 0
Not Completed 4 0
Reason Not Completed
Unsatisfactory therapeutic effect             1             0
Administrative problems             3             0
[1]
"Placebo" was not an arm in open label treatment.
Arm/Group Title Omalizumab Placebo Total
Hide Arm/Group Description

Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg. Total of all reporting groups
Overall Number of Baseline Participants 9 5 14
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 5 participants 14 participants
21  (4.1) 28  (9.5) 23  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 5 participants 14 participants
Female
5
  55.6%
1
  20.0%
6
  42.9%
Male
4
  44.4%
4
  80.0%
8
  57.1%
1.Primary Outcome
Title Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen
Hide Description [Not Specified]
Time Frame 6 months of blinded treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis was performed due to insufficient study enrollment
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description:
Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period
Hide Description [Not Specified]
Time Frame 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis was performed due to insufficient study enrollment
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description:

Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment
Hide Description [Not Specified]
Time Frame 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis was performed due to insufficient study enrollment
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description:
Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Steroid Free State.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis was performed due to insufficient study enrollment
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description:

Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Average Oral Corticosteroid Use.
Hide Description [Not Specified]
Time Frame 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis was performed due to insufficient study enrollment
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description:

Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline
Hide Description [Not Specified]
Time Frame 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis was performed due to insufficient study enrollment
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description:

Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Blinded Omalizumab Placebo Open Label Omalizumab
Hide Arm/Group Description Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg. Patients who completed double-blinded phase of the study, enrolled into 6 months open label phase and continued in the same regimen of omalizumab as they were during double-blinded phase. A maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
All-Cause Mortality
Blinded Omalizumab Placebo Open Label Omalizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Blinded Omalizumab Placebo Open Label Omalizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/9 (66.67%)   1/5 (20.00%)   4/7 (57.14%) 
Gastrointestinal disorders       
Distal intestinal obstruction syndrome  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Infections and infestations       
Bronchopulmonary aspergillosis allergic  1  2/9 (22.22%)  0/5 (0.00%)  0/7 (0.00%) 
Infective pulmonary exacerbation of cystic fibrosis  1  5/9 (55.56%)  1/5 (20.00%)  4/7 (57.14%) 
Lower respiratory tract infection bacterial  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Pneumonia  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Respiratory tract infection  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea exertional  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Haemoptysis  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Rhonchi  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Vascular disorders       
Hypertension  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Blinded Omalizumab Placebo Open Label Omalizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   5/5 (100.00%)   6/7 (85.71%) 
Congenital, familial and genetic disorders       
Cystic fibrosis lung  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Endocrine disorders       
Adrenal insufficiency  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Eye disorders       
Conjunctivitis  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Retinopathy hypertensive  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Gastrointestinal disorders       
Constipation  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Diarrhoea  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Nausea  1  1/9 (11.11%)  0/5 (0.00%)  1/7 (14.29%) 
Vomiting  1  0/9 (0.00%)  1/5 (20.00%)  3/7 (42.86%) 
General disorders       
Chills  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Device occlusion  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Exercise tolerance decreased  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Influenza like illness  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Injection site erythema  1  3/9 (33.33%)  0/5 (0.00%)  0/7 (0.00%) 
Injection site inflammation  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Injection site pain  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Injection site swelling  1  4/9 (44.44%)  0/5 (0.00%)  0/7 (0.00%) 
Injection site warmth  1  4/9 (44.44%)  0/5 (0.00%)  0/7 (0.00%) 
Medical device pain  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Non-cardiac chest pain  1  1/9 (11.11%)  1/5 (20.00%)  1/7 (14.29%) 
Oedema peripheral  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Pyrexia  1  3/9 (33.33%)  2/5 (40.00%)  2/7 (28.57%) 
Vessel puncture site haematoma  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Immune system disorders       
Food allergy  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Infections and infestations       
Gastroenteritis  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Gastrointestinal viral infection  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Infective pulmonary exacerbation of cystic fibrosis  1  6/9 (66.67%)  4/5 (80.00%)  3/7 (42.86%) 
Lower respiratory tract infection  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Lung infection  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Nasopharyngitis  1  2/9 (22.22%)  0/5 (0.00%)  2/7 (28.57%) 
Oral candidiasis  1  1/9 (11.11%)  0/5 (0.00%)  1/7 (14.29%) 
Oral herpes  1  1/9 (11.11%)  0/5 (0.00%)  1/7 (14.29%) 
Pharyngitis  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Pseudomonas infection  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Respiratory tract infection  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Sinusitis  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Upper respiratory tract infection  1  1/9 (11.11%)  0/5 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications       
Procedural pain  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Rib fracture  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Investigations       
Blood glucose increased  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Blood sodium decreased  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Liver function test abnormal  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Weight decreased  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/9 (11.11%)  0/5 (0.00%)  1/7 (14.29%) 
Hypokalaemia  1  2/9 (22.22%)  0/5 (0.00%)  2/7 (28.57%) 
Iron deficiency  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Vitamin K deficiency  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm skin  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Nervous system disorders       
Headache  1  4/9 (44.44%)  1/5 (20.00%)  3/7 (42.86%) 
Psychiatric disorders       
Anxiety  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchostenosis  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Cough  1  4/9 (44.44%)  1/5 (20.00%)  3/7 (42.86%) 
Haemoptysis  1  3/9 (33.33%)  0/5 (0.00%)  0/7 (0.00%) 
Increased upper airway secretion  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Oropharyngeal pain  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Respiratory tract congestion  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Rhonchi  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Sputum increased  1  1/9 (11.11%)  1/5 (20.00%)  2/7 (28.57%) 
Skin and subcutaneous tissue disorders       
Acne  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Erythema  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Rash  1  0/9 (0.00%)  1/5 (20.00%)  0/7 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  1/9 (11.11%)  0/5 (0.00%)  0/7 (0.00%) 
Flushing  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Hypertension  1  0/9 (0.00%)  0/5 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis's agreements with it's investigators vary. However, Novartis does not prohibit any investigator from publishing. Any publication from a single-center site are postponed until the publication of the pooled data ( i.e. data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00787917     History of Changes
Other Study ID Numbers: CIGE025A2437
First Submitted: November 7, 2008
First Posted: November 10, 2008
Results First Submitted: July 11, 2011
Results First Posted: August 4, 2011
Last Update Posted: September 26, 2011