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Ciclesonide comparison with fluticasone in mild persistent asthma

Comparison between ciclesonide and fluticasone in patients with mild persistant asthma asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201201028597N1
Enrollment
356
Registered
2012-04-03
Start date
2011-11-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma. Asthma, unspecified

Interventions

Intervention 1: Eligible patients are randomly divided to two groups and the intervention group patients will be assigned to receive ciclesonide 80mg once daily with spacer via inhalation. These patie
Treatment - Drugs
Eligible patients are randomly divided to two groups and the intervention group patients will be assigned to receive ciclesonide 80mg once daily with spacer via inhalation. These patients will be educ
Eligible patients are randomly divided to two groups and the control group patients will be assigned to receive fluticasone 100 mg twice daily with spacer via inhalation. These patients will be educat

Sponsors

Massih Daneshvari hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Ladies and gentlemen between 12 and 75 years as the definitive diagnosis of asthma is confirmed as mild persistent asthma: (Symptoms more than two days per week but less than daily incidence, symptoms at night more than two nights in month but less thatn every night, FEV1 = 80% predicted, FEV1 Variability% 20 -% 30 and the use of B2 agonists short acting more than two days a week but less than daily). Exclusion criteria: A) Having any of the criteria for moderate persistent asthma B) Pregnancy - Breastfeeding C) sensitivity to corticosteroids D) other lung diseases like COPD E) use of systemic corticosteroids in acute asthma attacks during two months before the run in period

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Forced expiratory volume in first second(FEV1). Timepoint: Before intervention and then 2,4, 8, 16 and 24 weeks after start of intervention. Method of measurement: Spirometry.

Secondary

MeasureTime frame
Forced vital capacity(FVC). Timepoint: Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Spirometry.;Number of asthma attacks. Timepoint: Any time it happened. Method of measurement: Recorded by patent himself/herself.;Total score of mini AQLQ questionare. Timepoint: Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Questionare will be completed by patients.;Nasopharyngitis as an adverse event. Timepoint: Before intervention and at 2, 4, 8, 16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Physical examination and laboratory investigations if needed.;Any adverse effect due to drug consumption. Timepoint: Before intervention and at 2, 4, 8,16 and 24 th week and in any time that the patient was referred due to adverse events. Method of measurement: Physical examination and laboratory investigations if needed.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026