Allergic Bronchopulmonary AspergillosisPhase 2/3NCT00974766
Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
A Phase 2/3 study testing Glucocorticoids in people with Allergic Bronchopulmonary Aspergillosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis
- What is being tested?
- Glucocorticoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2009to Mar 2011
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of ABPA
- Presence of all the following three criteria:
- immediate cutaneous hyperreactivity on aspergillus skin test
- elevated total IgE levels > 1000 IU/mL
- A fumigatus specific IgE levels > 0.35 kU/L, AND,
- Presence of two of the following criteria:
Show all 10Show fewer
- presence of serum precipitating antibodies against A fumigatus
- fixed or transient radiographic pulmonary opacities
- absolute eosinophil count > 1000/µL
- central bronchiectasis on HRCT
Who cannot join
- If they have taken glucocorticoids for more than three weeks in the preceding six months
- Failure to give informed consent
- Enrollment in another trial of ABPA
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.
The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Being tested
- Glucocorticoids
- Keywords
- bronchial asthma, allergic bronchopulmonary aspergillosis
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Prednisolone 0.5 mg/kg/day for 2 weeks; then 0.5 mg/kg/day for alternate days for eight weeks. Then taper by 5 mg every 2 weeks and discontinue
GlucocorticoidsDrug
Prednisolone 0.75 mg/kg/day for 6 weeks; then 0.5 mg/kg/day for 6 weeks. Then taper by 5 mg every 6 weeks and discontinue
| Study group | Role | What they receive |
|---|---|---|
| Low-dose glucocorticoid | Active comparator | Low-dose steroid Receives: Drug: Glucocorticoids |
| High-dose glucocorticoid | Active comparator | High-dose steroid Receives: Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucocorticoid-dependent ABPA
Measured: two year
relapse rates in the two groups
Measured: one year
Secondary outcomes (3)
time to first relapse
Measured: one year
glucocorticoid related adverse effects in the two groups
Measured: two years
response rates in the two groups
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Bronchopulmonary 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 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, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ritesh Agarwal, MD, DM, Principal investigator, Postgraduate Institute of Medical Education and Research, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974766
- Sponsor's protocol ID
- MS/723/Res/276
- Status last verified
- Feb 2015
- First submitted
- 9 Sep 2009
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Agarwal R, Aggarwal AN, Dhooria S, Singh Sehgal I, Garg M, Saikia B, Behera D, Chakrabarti A. A randomised trial of glucocorticoids in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Eur Respir J. 2016 Feb;47(2):490-8. doi: 10.1183/13993003.01475-2015. Epub 2015 Nov 19.
PubMed 26585431
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT00974766
- Acronym / sponsor ID
- MS/723/Res/276
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Keywords
- bronchial asthma, allergic bronchopulmonary aspergillosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Sep 2009 (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.
Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.
The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose glucocorticoid | Active comparator | Drug: GlucocorticoidsLow-dose steroid |
| High-dose glucocorticoid | Active comparator | Drug: GlucocorticoidsHigh-dose steroid |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of ABPA
- Presence of all the following three criteria:
- Presence of two of the following criteria:
Key exclusion criteria (3 listed)
- If they have taken glucocorticoids for more than three weeks in the preceding six months
- Failure to give informed consent
- Enrollment in another trial of ABPA
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 |
|---|---|---|
| GlucocorticoidsPrednisolone 0.5 mg/kg/day for 2 weeks; then 0.5 mg/kg/day for alternate days for eight weeks. Then taper by 5 mg every 2 weeks and discontinue | Drug | Low-dose glucocorticoid |
| GlucocorticoidsPrednisolone 0.75 mg/kg/day for 6 weeks; then 0.5 mg/kg/day for 6 weeks. Then taper by 5 mg every 6 weeks and discontinue | Drug | High-dose glucocorticoid |
Primary outcome
Glucocorticoid-dependent ABPA
Time frame: two year
relapse rates in the two groups
Time frame: one year
3 secondary outcomes
time to first relapse
Time frame: one year
glucocorticoid related adverse effects in the two groups
Time frame: two years
response rates in the two groups
Time frame: six weeks
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 24 Feb 2015.
- Derived from this study: PubMed 26585431Agarwal R, Aggarwal AN, Dhooria S, Singh Sehgal I, Garg M, Saikia B, Behera D, Chakrabarti A. A randomised trial of glucocorticoids in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Eur Respir J. 2016 Feb;47(2):490-8. doi: 10.1183/13993003.01475-2015. Epub 2015 Nov 19.
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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.
Ritesh Agarwal, MD, DM principal investigator
Postgraduate Institute of Medical Education and Research, Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glucocorticoids in people with Allergic Bronchopulmonary 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?
The sponsor lists 10 inclusion and 3 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 24 Feb 2015. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Glucocorticoid-dependent ABPA (time frame: two year). The study lists 2 primary outcomes in all. 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 NCT00974766, which also lists 1 linked publication.
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 24 Feb 2015.