Protocol summary

Study aim
Determining the effect of doxycycline in the treatment of asthma_like infections compared with classical treatment
Design
Clinical trial, double-blind, randomized, phase 2_3 on 50 patients. The randomized site was used for randomization.
Settings and conduct
pulmonary subspecialty clinic
Participants/Inclusion and exclusion criteria
Patient over 18 years with new infection with asthma-like symptoms for more than 6 weeks Cough, shortness of breath, stimulation with environmental factors and obstructive spirometry with reversibility of more than 12% with short-acting beta-agonist
Intervention groups
Patient over 18 years with new infection with asthma-like symptoms for more than 6 weeks Cough, shortness of breath, stimulation with environmental factors and obstructive spirometry with reversibility of more than 12% with short-acting beta-agonist
Main outcome variables
Wheezing at the physical examination Asthma attacks Recurrence of asthma Cough Dyspnea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220412054507N1
Registration date: 2022-04-18, 1401/01/29
Registration timing: retrospective

Last update: 2022-04-18, 1401/01/29
Update count: 0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Sara Nejati Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 9652
Email address
sarah.nejati.z@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-12, 1400/01/23
Expected recruitment end date
2022-02-12, 1400/11/23
Actual recruitment start date
2021-04-21, 1400/02/01
Actual recruitment end date
2022-01-21, 1400/11/01
Trial completion date
empty
Scientific title
Evaluation of the effect of doxycycline on asthma_like infection
Public title
effect of doxycycline on asthma_like infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient older than 18 years with new infection with asthma-like symptoms and signs for more than 6 weeks like cough,dyspnea,stimulation with environmental factors and obstructive spirometry with reversibility of more than 12% with short-acting beta-agonist
Exclusion criteria:
Pregnancy/GERD/Sensivity to Doxycycline/ Liver diseases
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Using https://www.randomizer.org, we randomly assign 50 codes to two groups of doxycycline and placebo. The drugs are all in the form of capsules with the same shape, size, color and packaging but different codes. Medications are given to a co-worker who is in our clinic and is unaware of the type of medication or placebo and the disease.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are given to a co-worker who is in our clinic and is unaware of the type of medication or placebo and the disease, so that patients can be given a package of medication.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, Islamic Azad University, Mashhad
Street address
Ostad Yusofi Street, Emamieh Boulevard ,GhasemAbad, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-413
Approval date
2021-05-19, 1400/02/29
Ethics committee reference number
IRI.IAU.MSHD.REC.1400.036

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Asthma treatment
Timepoint
In the beginning of the study, one and two months after taking the drugs
Method of measurement
ACT Questionnaire, Spirometry and Clinical sings and symptoms

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group is taken 100 mg doxycycline Cap twice a day for 15 days.
Category
Treatment - Drugs

2

Description
Control group: This group is taken 100 mg placebo twice a day for 15 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of lung and allergy
Full name of responsible person
Dr. Majid Mirsadraee
Street address
Iman Bldg, Between Kosar 6 and 4, Kosar Blvd,Mashhad, Khorasan Razavi province
City
Mashhad
Province
Razavi Khorasan
Postal code
98704347
Phone
+98 51 3870 4347
Email
Majidmirsadraee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Majid Mirsadraee
Street address
Ostad Yusofi Street, Emamieh Boulevard ,GhasemAbad, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-413
Phone
+98 51 3662 0154
Email
chief@mshdiau.ac.ir
Web page address
http://en.mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sponcer
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Nejati Zahmatkesh
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No 29, Rodaki 20, Rodaki st, Piroozi 4st,Piroozi Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9177894815
Phone
0098513878965
Email
Sarah.nejati.z@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Majid Mirsadraee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Iman bulding, kosar 4 and 6, Kosar blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
973870 4347
Phone
+98 51 3870 4347
Email
Majidmirsadraee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Nejati Zahmatkesh
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
29 no, Rodaki 20, Piroozi 4, Piroozi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177894815
Phone
+98 51 3878 9652
Email
Sarah.nejati.z@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Unlimited
To whom data/document is available
Students and researchers
Under which criteria data/document could be used
To conduct further research and expand knowledge
From where data/document is obtainable
Sending email is needed
What processes are involved for a request to access data/document
Sending email is needed
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