Status:
WITHDRAWN
Correct Use of Sequential Formoterol and Budesonide Inhaler Capsule Treatment Via Aerolizer and Patient Satisfaction in Asthmatics
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the correct use of sequential formoterol and budesonide inhaler capsule treatment via Aerolizer and patient satisfaction in adult asthmatics.
Eligibility Criteria
Inclusion
- Moderate persistent asthmatic patients.
- No previous Aerolizer experience.
Exclusion
- Life-threatening asthma: A subject must not have life-threatening asthma as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s).
- Worsening of asthma: A subject must not have experienced a worsening of asthma which involved a hospitalization within 6 months of screening, or an emergency room visit three or more times in the past 6 months, or use of oral corticosteroids for worsening asthma within 3 months of screening.
- Unstable asthma: During screening period, a patient requires the use of \>8 puffs/day of salbutamol 100 mcg per actuation pMDI on two consecutive days.
- A subject must not have had an upper respiratory tract infection within 4 weeks of screening.
- FEV1\< 60% at screening.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00997477
Start Date
June 1 2010
Last Update
April 20 2017
Active Locations (4)
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1
Novartis Investigator Site
Ankara, Turkey (Türkiye)
2
Novarits Investigator Site
Istanbul, Turkey (Türkiye)
3
Novartis Investigator Site
Istanbul, Turkey (Türkiye)
4
Novartis Investigator Site
Izmir, Turkey (Türkiye)