Chronic Cavitary Pulmonary AspergillosisPhase 4ITRACONASPNCT01259336
Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis
A Phase 4 study testing Itraconazole and treatment in cavitary pulmonary aspergillosis in people with Chronic Cavitary Pulmonary Aspergillosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Chronic Cavitary Pulmonary Aspergillosis
- What is being tested?
- Itraconazole and treatment in cavitary pulmonary aspergillosis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2010to Dec 2011
- Phase
- Phase 4
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Inclusion Criteria:
- Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks.
- Radiological findings:
- Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation.
- presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions.
- Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species.
- The diagnosis of CCPA will be made if
- Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria.
- FNAC from the cavity wall will be considered in atypical cases
- Exclusion Criteria:
- Invasive aspergillosis
- Allergic broncho-pulmonary aspergillosis (ABPA)
- Active tuberculosis or malignancy
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS
The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis
Read the detailed description
The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.
- Conditions
- Chronic Cavitary Pulmonary Aspergillosis
- Being tested
- Itraconazole, treatment in cavitary pulmonary aspergillosis
- Keywords
- Itraconazole, chronic cavitary pulmonary aspergillosis, Aspergillosis, fungal ball, mycetoma, efficacy, safety
- Medical subject headings
- Aspergillosis, Mycetoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Also called Study group
Tablet 200 mg twice daily for 6 months
treatment in cavitary pulmonary aspergillosisDrug
Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole | Active comparator | Role of itraconazole in CCPA Receives: Drug: Itraconazole; Drug: treatment in cavitary pulmonary aspergillosis |
| treatment in cavitary pulmonary aspergillosis | Experimental | Patients in this arm are given conservative management with antitussives, brochial artery embolisation. Receives: Drug: treatment in cavitary pulmonary aspergillosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement in cough and hemoptysis
Clinical response- assessed by a decrease in frequency \& intensity of hemoptysis \& cough. Significant clinical response will be considered if there is no recurrence of episodes of moderate-massive hemoptysis. Number of interventions required to control hemoptysis will also be taken as a measure of clinical response
Measured: 6 months
Secondary outcomes (1)
Radiological response of CCPA to itraconazole
- Complete response- It is defined as complete disappearance of the aspergilloma.
- Partial response- It is defined as 30% decrease in the sum of the longest diameters of all the lesions.
- Progressive disease- It is defined as appearance of any new lesions or >20% increase in the sum of the longest diameters of all measurable lesions.
- Stable disease- Shrinkage or growth of CCPA that does not meet any of these criteria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Cavitary Pulmonary AspergillosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishwanath gella, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Vishwananath gella, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259336
- Sponsor's protocol ID
- Itracon asp
- Acronym
- ITRACONASP
- Status last verified
- Nov 2010
- First submitted
- 6 Dec 2010
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stevens DA, Kan VL, Judson MA, Morrison VA, Dummer S, Denning DW, Bennett JE, Walsh TJ, Patterson TF, Pankey GA. Practice guidelines for diseases caused by Aspergillus. Infectious Diseases Society of America. Clin Infect Dis. 2000 Apr;30(4):696-709. doi: 10.1086/313756. Epub 2000 Apr 20.
PubMed 10770732Agarwal R, Vishwanath G, Aggarwal AN, Garg M, Gupta D, Chakrabarti A. Itraconazole in chronic cavitary pulmonary aspergillosis: a randomised controlled trial and systematic review of literature. Mycoses. 2013 Sep;56(5):559-70. doi: 10.1111/myc.12075. Epub 2013 Mar 18.
PubMed 23496375
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS
- ClinicalTrials.gov ID
- NCT01259336
- Acronym / sponsor ID
- ITRACONASP / Itracon asp
- Conditions
- Chronic Cavitary Pulmonary Aspergillosis
- Keywords
- Itraconazole, chronic cavitary pulmonary aspergillosis, Aspergillosis, fungal ball, mycetoma, efficacy, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Dec 2010 (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.
The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis
Detailed description
The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole | Active comparator | Drug: Itraconazole, Drug: treatment in cavitary pulmonary aspergillosisRole of itraconazole in CCPA |
| treatment in cavitary pulmonary aspergillosis | Experimental | Drug: treatment in cavitary pulmonary aspergillosisPatients in this arm are given conservative management with antitussives, brochial artery embolisation. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| ItraconazoleAlso: Study groupTablet 200 mg twice daily for 6 months | Drug | Itraconazole |
| treatment in cavitary pulmonary aspergillosisAnti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE) | Drug | Itraconazole, treatment in cavitary pulmonary aspergillosis |
Primary outcome
clinical improvement in cough and hemoptysis
Time frame: 6 months
Clinical response- assessed by a decrease in frequency \& intensity of hemoptysis \& cough. Significant clinical response will be considered if there is no recurrence of episodes of moderate-massive hemoptysis. Number of interventions required to control hemoptysis will also be taken as a measure of clinical response
1 secondary outcome
Radiological response of CCPA to itraconazole
Time frame: 6 months
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 22 Feb 2012.
- Background: PubMed 10770732Stevens DA, Kan VL, Judson MA, Morrison VA, Dummer S, Denning DW, Bennett JE, Walsh TJ, Patterson TF, Pankey GA. Practice guidelines for diseases caused by Aspergillus. Infectious Diseases Society of America. Clin Infect Dis. 2000 Apr;30(4):696-709. doi: 10.1086/313756. Epub 2000 Apr 20.
- Derived from this study: PubMed 23496375Agarwal R, Vishwanath G, Aggarwal AN, Garg M, Gupta D, Chakrabarti A. Itraconazole in chronic cavitary pulmonary aspergillosis: a randomised controlled trial and systematic review of literature. Mycoses. 2013 Sep;56(5):559-70. doi: 10.1111/myc.12075. Epub 2013 Mar 18.
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.
Vishwananath gella, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Itraconazole and treatment in cavitary pulmonary aspergillosis in people with Chronic Cavitary Pulmonary Aspergillosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Feb 2012. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
clinical improvement in cough and hemoptysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259336, which also lists 2 linked publications.
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 22 Feb 2012.