This study was conducted to determine the effect of oral low dose Theophylline on serum CRP in patients with stable COPD referred to specialized Tohid Hospital clinics and private clinic in Sanandaj 1387. This is a double blind randomized clinical trial study. Fifty patients (25 in experimental group and 25 in placebo group) were enrolled into the study on the basis of block randomization method. Inclusion criteria include stable COPD (no exacerbation in the past two months), FEV1/FVC ratio less than 70%. Serum CRP levels were evaluated by ELISA sensitive HS-CRP method, and then slowly release Theophylline tablets with dose of 200 mg every 12 hours in the intervention group and the placebo in the control group was administered for one month and again at the end of the study HS-CRP was measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808182685N1
Registration date:2009-12-05, 1388/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-12-05, 1388/09/14
Registrant information
Name
Naseh Sigari
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1328 6113
Email address
naseh46@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Kurdistan University of Medical Sciences
Expected recruitment start date
2008-12-05, 1387/09/15
Expected recruitment end date
2009-03-05, 1387/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low-dose oral Theophylline on serum HS-CRP in patients with stable COPD
Public title
The effect of low-dose oral Theophylline drug on active c serum protein level in patients with stable chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: stable COPD (no exacerbation in the past two months), FEV1/FVC ratio less than 70%.
Exclusion criteria: no smoking history, FEV1 increased more than 200 cc or 12% after administration of 400 micrograms spray Salbutamol in spirometry, clinical or radiographic evidence of pneumonia, history of infectious disease such as tuberculosis, recent respiratory tract infections, bronchiectasis, acute or chronic diarrhea, rheumatoid arthritis, degenerative disease of large joint, vasculitis, and the possibility of malignancy based on history and examination and Theophylline use during a month prior to the enrollment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Vice-chancellor for Research, Kurdistan University of Medical Sciences, Pasdaran Street,
City
Sanandaj
Postal code
13446-66177
Approval date
2008-12-22, 1387/10/02
Ethics committee reference number
9045 پ/14/پ
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J40, J43
ICD-10 code description
chronic Bronchitis, Emphysema with FEV1<70
Primary outcomes
1
Description
HS-CRP serum levels
Timepoint
Before and after intervention
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Placebo with dose of 200 mg every 12 hours for one month
Category
Placebo
2
Description
Theophylline tablets, 200 mg every 12 hours for one month