Evaluation of the effectiveness of Tiotropium bromide in patients with severe asthma
Design
Randomized Placebo_controlled , Crossover and double blinded Trial
Settings and conduct
After obtaining approval from the Ethics Committee, patients are randomly assigned to two groups of placebo and intervention. In the intervention group, in addition to routine treatment, Tiotropium bromide is prescribed. After 4 weeks, the variables are checked in two groups and after a 4-week washout period, the group that receive the placebo receive the drug (Tiotropium bromide) , and the group receiving the drug Tiotropium bromide receives placebo and after a 4-week period, the variables are re_evaluated in two groups. Thiotropium bromide and placebo are named as code, and health care personnel and patients are not aware of the type.
Participants/Inclusion and exclusion criteria
Entering conditions: Patients with severe asthma who have been treated with routine anti-asthma drugs and Being under treatment with routine anti-asthma drugs
and Labeled as grade 4 or 5 of asthma.
Not-entering conditions:
Pregnancy
lactation (Breastfeeding)
Using hormonal contraceptives drugs
High pregnancy probability
Chronic obstructive pulmonary disease (COPD)
Having other pulmonary diseases
Infection of the respiratory system
Audio cord performance dysfunction
smokers with more than 10 pack per year
History of taking muscarinic anticholinergic drugs
History of taking other anticholinergic drugs
Inability to use the drugs prescribed in this study
Intervention groups
Patients are divided into two groups of placebo and intervention. In the intervention group, in addition to routine treatment, Tiotropium bromide is prescribed.
Main outcome variables
Forced expiratory volume in 1 second (FEV1)
,asthma control test (ACT) score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181015041353N1
Registration date:2018-11-01, 1397/08/10
Registration timing:prospective
Last update:2018-11-01, 1397/08/10
Update count:0
Registration date
2018-11-01, 1397/08/10
Registrant information
Name
Seyed Mohammad Ali Mir Jahanbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5564
Email address
dr.mirjahan@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of Tiotropium bromide in patients with severe asthma
Public title
The effectiveness of Tiotropium bromide in patients with severe asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe asthma who have been treated with routine anti-asthma drugs
Being under treatment with routine anti-asthma drugs
Labeled as grade 4 or 5 of asthma
Age of 18 years and more
Exclusion criteria:
Pregnancy
lactation (Breastfeeding)
Using hormonal contraceptives drugs
High pregnancy probability
Chronic obstructive pulmonary disease (COPD)
Having other pulmonary diseases
Infection of the respiratory system
Audio cord performance dysfunction
smokers with more than 10 pack per year
History of taking muscarinic anticholinergic drugs
History of taking other anticholinergic drugs
Inability to use the drugs prescribed in this study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to either placebo group or intervention using permuted block randomization.Permuted block randomization is a way to randomly allocate a participant to a treatment group, while maintaining a balance across treatment groups. Each “block” has a specified number of randomly ordered treatment assignments.
Blinding (investigator's opinion)
Double blinded
Blinding description
Samples and clinical personnel (physicians , nurses ,physiotherapists and etc) who have responsibility of taking care of the patients and who ever has any direct contact with samples are blinded and researcher and and evaluator and The Data and Safety Monitoring Board (DSMB) are not blinded.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463i
Approval date
2018-08-12, 1397/05/21
Ethics committee reference number
IR.ZAUMS.REC.1397.199
Health conditions studied
1
Description of health condition studied
Moderate persistent asthma with status asthmaticus
ICD-10 code
J45.42
ICD-10 code description
Moderate persistent asthma with status asthmaticus
2
Description of health condition studied
Severe persistent asthma
ICD-10 code
J45.5
ICD-10 code description
Severe persistent asthma
Primary outcomes
1
Description
Forced expiratory volume in 1 second (FEV1)
Timepoint
At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period.
Method of measurement
Spirometry
2
Description
asthma control test (ACT) score
Timepoint
At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period.
Method of measurement
By test score
Secondary outcomes
1
Description
The need for oral or injection of steroids
Timepoint
At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period.
Method of measurement
By the physician
2
Description
Need of hospitalization
Timepoint
At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period.
Method of measurement
By the physician
Intervention groups
1
Description
Intervention group: Name of drug : Capsule - Inhalation Tiotropium bromide 18 micrograms daily (one puff daily) for 4 weeks separately in phase 1 and 2, Made in India by CIPA
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Lung clinic of Ali Ibne Abitaleb Hospital
Full name of responsible person
Dr.Nazar Ali Moulaei
Street address
Salamat Blvd., Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5564
Fax
+98 54 3329 5563
Email
moulaei@zaums.ac.ir
Web page address
http://www.alihos.zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Noor Mohammad Bakhshani
Street address
ZAUMS Main campus, DoctorHesabi Square , Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Fax
Email
moulaei@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical 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
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ali Mir Jahanbakhsh
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali ibne abitaleb Hospital, Salamat Blvd., Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5564
Fax
+98 54 3329 5563
Email
dr.mirjahan@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ali Mir Jahanbakhsh
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali ibne abitaleb Hospital, Salamat Blvd., Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5564
Fax
+98 54 3329 5563
Email
dr.mirjahan@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ali Mir Jahanbakhsh
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali ibne abitaleb Hospital, Salamat Blvd., Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5564
Fax
+98 54 3329 5563
Email
dr.mirjahan@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available