COPDDOLE-COPDNCT06915688
A Study Comparing Doxycycline and Levofloxacin for Treating COPD Exacerbations
A study testing Doxycycline and Levofloxacin in people with COPD, run by Amina Aslam at 1 site in Pakistan.
Trial summary
This study will include patients with chronic obstructive pulmonary disease (COPD) who present with an acute exacerbation. Participants will be randomly assigned to receive either doxycycline or levofloxacin for 5 days. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Doxycycline and Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed cases of COPD Exacerbation of COPD Able to provide Written consent No anti biotic taken with in past 4 weeks
Who cannot join
- hypersensitivity to any drugs Pneumonia evidence on xray/ hrct chest Any other pulmonary condition e.g asthma Pregnancy/breast feeding Taking treatment for other active infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
General hospital
Lahore
zaeema Dogar, Mbbs, 03474024597, zaeemakanwal@hotmail.com
Mubashir Aslam, Mbbs, 03024748021
About this study
Official title: Comparison of Clinical Cure Rate of Doxycycline and Levofloxacin in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
This study will include patients with chronic obstructive pulmonary disease (COPD) who present with an acute exacerbation. Participants will be randomly assigned to receive either doxycycline or levofloxacin for 5 days. The aim is to compare how effective each antibiotic is in improving symptoms after 2 days of treatment.
Read the detailed description
This randomized controlled trial will evaluate the effectiveness of two antibiotics-doxycycline (a tetracycline) and levofloxacin (a fluoroquinolone)-in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Participants will be assigned to one of the two treatment groups and will receive either doxycycline 100 mg twice daily or levofloxacin 500 mg once daily for 5 days. The primary outcome is clinical cure. This will be evaluated 2 days after completion of antibiotic therapy, based on symptom resolution and laboratory markers.
- Conditions
- COPD
- Being tested
- Doxycycline, Levofloxacin
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline will be given to COPD group 1
LevofloxacinDrug
Levofloxacin given to copd patients
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Doxycycline will be given to this group Receives: Drug: Doxycycline |
| Arm 2 | Active comparator | Levofloxacin in copd patients Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate
- A decrease in the respiratory rate by 20% from the baseline measurement.
- Restoration of Oxygen saturation levels to within the range of 88-92% on room air.
- CRP<10ng/ml
- decrease in sputum quantity
- reduction in body temperature below 99•F
- TLC <11,000
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion28 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amina Aslam
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Amina Aslam, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915688
- Sponsor's protocol ID
- LGH-COPD-2025
- Acronym
- DOLE-COPD
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Cure Rate of Doxycycline and Levofloxacin in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06915688
- Acronym / sponsor ID
- DOLE-COPD / LGH-COPD-2025
- Conditions
- COPD
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Amina AslamOther government
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 8 Apr 2025 (actual)
- 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.
This study will include patients with chronic obstructive pulmonary disease (COPD) who present with an acute exacerbation. Participants will be randomly assigned to receive either doxycycline or levofloxacin for 5 days. The aim is to compare how effective each antibiotic is in improving symptoms after 2 days of treatment.
Detailed description
This randomized controlled trial will evaluate the effectiveness of two antibiotics-doxycycline (a tetracycline) and levofloxacin (a fluoroquinolone)-in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Participants will be assigned to one of the two treatment groups and will receive either doxycycline 100 mg twice daily or levofloxacin 500 mg once daily for 5 days. The primary outcome is clinical cure. This will be evaluated 2 days after completion of antibiotic therapy, based on symptom resolution and laboratory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: DoxycyclineDoxycycline will be given to this group |
| Arm 2 | Active comparator | Drug: LevofloxacinLevofloxacin in copd patients |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed cases of COPD Exacerbation of COPD Able to provide Written consent No anti biotic taken with in past 4 weeks
Key exclusion criteria (1 listed)
- hypersensitivity to any drugs Pneumonia evidence on xray/ hrct chest Any other pulmonary condition e.g asthma Pregnancy/breast feeding Taking treatment for other active infections
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 |
|---|---|---|
| DoxycyclineDoxycycline will be given to COPD group 1 | Drug | Arm 1 |
| LevofloxacinLevofloxacin given to copd patients | Drug | Arm 2 |
Primary outcome
Clinical Cure Rate
Time frame: 7 days
1. A decrease in the respiratory rate by 20% from the baseline measurement. 2. Restoration of Oxygen saturation levels to within the range of 88-92% on room air. 3. CRP<10ng/ml 4. decrease in sputum quantity 5. reduction in body temperature below 99•F 6. TLC <11,000
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline and Levofloxacin in people with COPD, run by Amina Aslam at 1 site in Pakistan.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Apr 2025. 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 Pakistan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amina Aslam, MBBS (+923024748021, mubashirm384@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure Rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
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 8 Apr 2025.