| CTRI Number |
CTRI/2012/01/002328 [Registered on: 09/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
06/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine whether doxycycline, an antibiotic, can help patients with bronchial asthma. |
|
Scientific Title of Study
|
Open prospective single arm real practice trial of long term doxycycline in asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare & Research |
| Address |
Ak-46, Salt Lake
CB-16, Salt Lake.Kolkata-700064.
Kolkata
WEST BENGAL
700091
India |
| Phone |
03323215152 |
| Fax |
03323580424 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare & Research |
| Address |
Ak-46, Salt Lake
CB-16, Salt Lake.Kolkata-700064.
Kolkata
WEST BENGAL
700091
India |
| Phone |
9831003144 |
| Fax |
9831003144 |
| Email |
parthachest@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parthasarathi Bhattacharyya |
| Designation |
Principal Investigator |
| Affiliation |
Institute of Pulmocare & Research |
| Address |
Ak-46, Salt Lake
CB-16, Salt Lake.Kolkata-700064.
Kolkata
WEST BENGAL
700091
India |
| Phone |
9831003144 |
| Fax |
9831003144 |
| Email |
parthachest@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Pulmocare & Research |
|
|
Primary Sponsor
|
| Name |
Institute of Pulmocare Research |
| Address |
AK-46 Salt Lake,Kolkata-700091 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Pulmocare and Research |
CB-16, Salt Lake, Kolkata-700064 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parthasarathi Bhattacharyya |
Institute of Pulmocare and Research |
Off address:CB-16, Salt Lake, Kolkata-700064
Department: Clinical Research
Kolkata
WEST BENGAL |
9831003144
ipcr_india@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline |
Doxycycline 100mg used orally twice daily after one hr of taking meals. The drug will be used for at least 6 months
; if improved may be continued even beyond one year. |
| Comparator Agent |
No comparator |
Since it is a single arm trial no comparator drug/agent was used. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a) Willing to participate in the trial.
b) History of SOB with wheeze with variability (seasonal, diurnal, others) with h/o spontaneous recovery (wellbeing) or relief from oral or inhaled bronchodialators with or without family history of diagnosed or suggestive asthma and / or allergic rhinitis with documentation of airflow limitation with or without reversibility.
c) Thus both certain and possible cases of chronic asthmatics will be incorporated.
|
|
| ExclusionCriteria |
| Details |
i) Age 13 yrs and75yrs
ii) Unwillingly for informed written consent
iii) H/o doxycycline intolerance
iv) Very sick patient unable for follow up.
v) Significant Co-morbidity – that can affect the spirometric performance or the synptomatology.
vi) FEV160% of predicted value
vii) Clinically obvious anemia and HB% if measured 7.0 gm%
viii) Pregnancy and lactation
ix) Exacerbation in last 6 weeks.
x) No other obvious lung disease as assessed by the physician
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in both pre and post FEVI |
preferably at least 6 months of continuation of doxycycline therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Brief
findings:
·
Actual
number of patients enrolled 24.
·
10
patients are continuing the therapy, but the second Spirometry is pending.
·
4
patients consumed inconsistently – dropped and stopped.
·
1
patients started very recently – not included
·
2
patients had stopped the therapy after a few days without any side effects.
·
1
patient was diagnosed TB, Doxycycline stopped.
6
patients are incorporated for statistical analysis:
Mean
age: 47.0±14.6 years
Mean
duration: 162.83±83.07 days
|
|
Before treatment
|
After treatment
|
|
|
Mean ± SD
|
Mean ± SD
|
|
FEV1(L)(post-bronchodialators)
|
1.30±0.43
|
1.61±0.34
|
Significance
p-value = 0.004
|