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Role of an antibiotic in chronic cough and breathlessness

A one year phase III randomized, open, parallel group study to know the role of doxycycline in treatment of chronic obstructive pulmonary disease.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001873
Enrollment
124
Registered
2011-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- COPD

Interventions

Intervention1: Doxycycline.: It is an antibiotic,available in the market for last 30 yrs.It is orally used,100mg tablet or capsule twice daily after taking food.For this study duration of therapy is o

Sponsors

Dr Parthasarathi Bhattacharyya
Lead Sponsor
Institute of Pulmocare Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria i) Male or female adult aged more than equal 40 years years who has signed an written informed consent form prior to initiation of any study and related procedure ii) Patients of severe to very severe COPD according to the GOLD guideline criteria 2008. The COPD being diagnosed as FEV1/FVC less than 70 %, FEV1 less than 80 %, and pre bronchodilator FEV1 being essentially below 50% of predicted.

Exclusion criteria

Exclusion criteria: i) Age less than 40 years and more than 75 years ii) Unwillingly for informed written consent iii) H/o doxycycline intolerance iv) Very sick patient likely unable to perform the spirometry and comply to the required follow up protocol. v) Patients who, in the judgment of the investigator, have a clinically significant co-morbidity, or laboratory abnormality ? that can affect the spirometric performance or the overall symptomatology, or can increase the risk of morbidity if enrolled in the protocol (viz, unstable angina, recent MI) vi) Patient with concomitant pulmonary disease, e.g. (active pulmonary tuberculosis, clinically significant bronchiectasis, sarcoidosis, interstitial lung disease etc. vii) Pregnancy and lactation and women with child bearing potential viii) Exacerbation in last 4 weeks requiring antibiotics and/or steroid ix) History of hospitalization for any reason within last 4 weeks of screening x) Patients with lung lobectomy, lung volume reduction or lung transplantation done in past xi) Any vaccination (flu or pneumococcal) within two days of randomization

Design outcomes

Primary

MeasureTime frame
Change in FEV1 in terms of no reduction or improvement in doxycycline treated COPD patients compared to the standard treatment.Timepoint: One year

Secondary

MeasureTime frame
NilTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Parthasarathi Bhattacharyya

Consultant

parthachest@yahoo.com03323212919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026