Double-blind Randomized Clinical Trial with Control and Parallel Groups
Settings and conduct
20 Patients with Asthma Were Entered into This Study Based on History and Spirometry. The Patients Were Selected from People Who Referred to the Pulmonary Clinic of Imam Khomeini Hospital. Qualified People Were Randomly Divided into Two Groups of 10. Each Group Received High-dose Inhaled Corticosteroids, Long-acting Beta-agonists, Anticholinergic Inhalants and Oral
Corticosteroids in a Dose of 5 mg Daily. The First Group Received Taladafil 50 mg daily and the Second Group Received the Same Dose of Placebo. Before Starting the Study, Spirometry, Lung Volume, a Quality of Life Questionnaire and 6MWD Test Were Performed on Patients. َAfter one Month, Spirometry, lung volume, a Quality of Life Questionnaire and 6MWD Test Were Done and Evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criterion: the patients with severe asthma. Exclusion criteria: mild to moderate severity; using immunosuppressive drug and corticosteroid ( greater than 5 mg dose); pregnancy; advanced liver or renal failure; any untreated disease and uncontrolled hypertension
Intervention groups
The Patients Were Divided into Groups Receiving Taladafil and Placebo. Intervention Group Received a Single 50 mg Dose of Oral Taladafil (Made in Ahvaz Pharmacy Faculty) Daily during One Month. The Control Group also Received a Single 50 mg Dose of Oral Placebo (Made in Ahvaz Pharmacy Faculty) Daily during One Month.
Main outcome variables
Lung Volumes (Forced expiratory volume in one second); (Forced Vital Capacity) ; (Forced Expiratory flow 25_75 %); Forced Expiratory Volume in 1 Second to Forced Vital Capacity; Quality of Life Score; Walking Distance upon 6 Minute Walking Distance Test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200823048482N1
Registration date:2020-09-09, 1399/06/19
Registration timing:prospective
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Seyed Ali Asghar Fakhr Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 7410
Email address
fakhrmousavi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2020-12-30, 1399/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Taladafil on Improvement of Lung Function and Asthma Attacks in Patients with Severe Asthma
Public title
Evaluating the Effect of Taladafil on the Treatment of Severe Asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Patients with Severe Asthma
Exclusion criteria:
Mild to moderate severity
Using Immunosuppressive Drug and Corticosteroid ( Greater than 5 mg Dose) Outside the Study Protocol in Three Months Ago
Advanced Liver Failure (Liver Cirrhosis), Advanced Renal Failure (CKD Stage 4,5)
Pregnancy
Uncontrolled Hypertension
Havingany Untreated Disease such as Reflux, Sinusitis or Allergic Bronchopulmonary Aspergillosis (ABPA) based on History and Paraclinical Tests which Trigger Asthma Exacerbation Continuously
Prohibition of Phosphodiesterase Inhibitors and Nitrate Consumption
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized Numbers from 1 to 20 Was Produced with a Calculator. The First 10 Numbers Allocated to Intervention Group and the Other 10 Numbers Allocated to Control Group, Then Drug Pockets Sequentially from 1 to 20, Was Given to Researcher for Prescription to Patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the Drugs Were in Similar and Dark Pockets, There Was One Numerical Label upon Them. Only Chemist Was Aware from Specific Number that Allocated to Specific Group.Then Drug Pockets Given to Researcher to Prescript and Deliver to Patients, Sequential from 1 to 20.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.AJUMS.REC.1398.920
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Lung Volume (Forced expiratory volume in one second); (FEV1)