AspergillosisPhase 2NCT00005668
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
A Phase 2 study testing Itraconazole oral solution in people with Aspergillosis and Lung Diseases, Fungal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma. Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspergillosis, Lung Diseases, Fungal
- What is being tested?
- Itraconazole oral solution
- Type of treatment
- Pill or oral medicine
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are 18 years of age or older.
- Have been diagnosed with aspergilloma within the last month.
- Have (or have a history of) at least one of the following:
- positive test for Aspergillus species.
- presence of antibodies to Aspergillus.
Show all 10Show fewer
- Are willing to participate in the study for 2 full years.
- Are female and not pregnant.
- Are not breast-feeding.
- Agree to use barrier methods of birth control / contraception during the study and for 30 days after.
Who cannot join
- You will not be eligible for this study if you:
- Have a history of allergy to triazole or imidazole drugs.
- Are unable to take oral medication.
- Are not expected to live for more than a month.
- Have had a lung biopsy indicating Aspergillus infection.
- Have had radiation therapy within the last 6 months.
Show all 9Show fewer
- Require treatment with certain medications.
- Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.
- Received chemotherapy within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.
Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.
Read the detailed description
Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.
- Conditions
- Aspergillosis, Lung Diseases, Fungal
- Being tested
- Itraconazole oral solution
- Medical subject headings
- Aspergillosis, Lung Diseases, Fungal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole oral solutionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 96 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005668
- Sponsor's protocol ID
- DMID MSG 37
- Other IDs
- DMID 96-199, NIH/09021
- Status last verified
- Nov 2005
- First submitted
- 18 May 2000
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
- ClinicalTrials.gov ID
- NCT00005668
- Acronym / sponsor ID
- DMID MSG 37
- Conditions
- Aspergillosis, Lung Diseases, Fungal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Nov 2005
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.
Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.
Detailed description
Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Are 18 years of age or older.
- Have been diagnosed with aspergilloma within the last month.
- Have (or have a history of) at least one of the following:
- Are willing to participate in the study for 2 full years.
- Are female and not pregnant.
Key exclusion criteria (9 listed)
- Have a history of allergy to triazole or imidazole drugs.
- Are unable to take oral medication.
- Are not expected to live for more than a month.
- Have had a lung biopsy indicating Aspergillus infection.
- Have had radiation therapy within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itraconazole oral solution | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
Related trials for Aspergillosis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itraconazole oral solution in people with Aspergillosis and Lung Diseases, Fungal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.