ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment)
This study has been completed.
Sponsor:
Elpen Pharmaceutical Co. Inc.
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01475045
First received: October 12, 2011
Last updated: November 18, 2011
Last verified: November 2011
| Tracking Information | |||||
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| First Received Date ICMJE | October 12, 2011 | ||||
| Last Updated Date | November 18, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patients' satisfaction [ Time Frame: all study period (5 months) ] [ Designated as safety issue: No ] Patients' replies to FSI-10 questionnaire valid in Greek language |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01475045 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Patients devices' use [ Time Frame: all study period (5 months) ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment) | ||||
| Official Title ICMJE | Multicenter, Prospective, Non Interventional Observational Study in Treatments of Asthma and Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Brief Summary | The aim of the study is to compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire |
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| Detailed Description | Patients are requested to reply to FSI-10 questionnaire regarding their satisfaction from inhalation devices. Patients are on 3 different asthma inhalation devices with combination treatment (Turbuhaler, Diskus, Elpenhaler) |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Three subgroups of patients who are already in their inhalation treatment (devices: Discus, Elpenhaler, Turbuhaler) are asked to complete the FSI-10 questionnaire valid in Greek language. The questionnaire responses indicate their satisfaction by their treatment devices. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1160 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01475045 | ||||
| Other Study ID Numbers ICMJE | 20109-HAL-EL-02, Sponsor ID | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Elpen Pharmaceutical Co. Inc. | ||||
| Study Sponsor ICMJE | Elpen Pharmaceutical Co. Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Elpen Pharmaceutical Co. Inc. | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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