Comparative study of the effect of levofloxacin with azithromycin in improving pulmonary function in patients with exacerbated bronchiectasis, a double-blind clinical trial
Comparative study of the effect of levofloxacin with azithromycin in improving pulmonary function in patients with exacerbated bronchiectasis
Design
This double blind clinical trial is performed on 72 patients with exacerbated bronchiectasis that randomly divided into two equal groups In parallel. Block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose; 23 blocks with 4 subjects in each block will be used. For selecting each blocks; statistical software and the block number will be selected.
Settings and conduct
This study was conducted as a clinical trial study with 72 patients who referred to lung ward of Imam Hossain Hospital of Shahroud. In this study the evaluator and analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with definite diagnosis of aggravated non-fibrocystic bronchiectasis disease; Not having moderate to severe heart failure (EF>50); Stable vital signs; Having a controlled and stable drug regimen during the study. Exclusion criteria: Gastrointestinal problems such as severe nausea and vomiting; various cancers of the respiratory system; chronic kidney and liver disease at the same time; History of any surgery on the respiratory system at least in the last year; A history of receiving any antibiotics and corticosteroid drugs in the last month; and pregnancy and breastfeeding.
Intervention groups
In intervention group, routine treatment + levofloxacin tablets 250 mg twice a day for two weeks and then 250 mg once a day for four weeks (6 weeks in total) will be prescribed. For patients in the control group, routine treatment + azithromycin tablets 250 mg twice a day for two weeks and then 250 mg once a day for four weeks (6 weeks in total) will be prescribed.
Main outcome variables
Measuring oxygen saturation (o2sat) and measurement of lung volumes and capacities.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N28
Registration date:2022-09-01, 1401/06/10
Registration timing:prospective
Last update:2022-09-01, 1401/06/10
Update count:0
Registration date
2022-09-01, 1401/06/10
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-11, 1401/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of levofloxacin with azithromycin in improving pulmonary function in patients with exacerbated bronchiectasis, a double-blind clinical trial
Public title
Comparing the effect of levofloxacin with azithromycin in improving pulmonary function of patients with bronchiectasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with definite diagnosis of aggravated non-fibrocystic bronchiectasis disease;
Not having moderate to severe heart failure (EF>50);
Stable vital signs;
Having a controlled and stable drug regimen (according to the opinion of a pulmonologist) during the study;
Informed consent to participate in research.
Exclusion criteria:
Gastrointestinal problems such as severe nausea and vomiting;
The presence of various cancers of the respiratory system;
The presence of chronic kidney and liver disease at the same time;
History of any surgery on the respiratory system at least in the last year;
A history of receiving any antibiotics in the last month;
A history of receiving any corticosteroid drugs in the past month;
Pregnancy and breastfeeding.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block. Random unit: individual. َRandomization tool: An online randomization website. Sequence building: using block randomization method with block size of 4. Concealing method: using closed and opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, clinical evaluator and analyzer are blinded. The allocation of patients into two groups A and B is done by a qualified nurse who has no aware of the actions performed in the two groups.
Clinical examination and outcome evaluation will be record by a qualified nurse without any information about the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer; Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2022-07-30, 1401/05/08
Ethics committee reference number
IR.SHMU.REC.1401.126
Health conditions studied
1
Description of health condition studied
Bronchiectasis
ICD-10 code
J47.1
ICD-10 code description
Bronchiectasis with (acute) exacerbation
Primary outcomes
1
Description
Measuring oxygen saturation (o2sat)
Timepoint
Once every two weeks
Method of measurement
Standard method with pulse oximetry device
2
Description
Measurement of lung volumes and capacities
Timepoint
Once every two weeks
Method of measurement
Standard method with spirometer
Secondary outcomes
1
Description
Measuring discomfort from breathing (Dyspnea)
Timepoint
Once every two weeks
Method of measurement
Using standard Borg questionnaire
2
Description
Measurement of white blood cells
Timepoint
Once every two weeks
Method of measurement
By standard laboratory method
Intervention groups
1
Description
Intervention group: For patients in the intervention group, after justifying the patients and providing the necessary training, routine treatment includes: use of oxygen, bronchodilators, expectorant drugs + levofloxacin tablets 250 mg twice a day for two weeks and then 250 mg once a day for four weeks (6 weeks in total) will be prescribed.
Category
Treatment - Drugs
2
Description
Control group: For patients in the control group, after justifying the patients and providing the necessary training, routine treatment will include: use of oxygen, bronchodilators, expectorant drugs + azithromycin tablets 250 mg twice a day for two weeks and then 250 mg once a day for four weeks (6 weeks in total) will be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr. Maryam Hagimirghasemi
Street address
Imam Hossein Hospital., End Imam street., Shahroud; Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
drhagimirghasemi@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Imamian
Street address
Vice chancellor for research; Shahroud University medical Sciences; 7th Tir squar; Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Bibimahsa Forghani
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Hossein Hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
daaroo85@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Maryam Hagimirghasemi
Position
Pulmonologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Hossein hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
drhagimirghasemi@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available