Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Marketed antagonists

• Registration Number: NCT02419872
• Lead Sponsor: Teva Pharmaceuticals Europe

Brief Summary

The study is to evaluate the percentage of patients with asthma or COPD achieving disease control

Detailed Description

There are no treatment groups or interventions to which the patients can be randomly assigned. Data will be collected in a routine setting on a single occasion during an otherwise normal visit at the physician's office or clinic. Participating physicians will not perform any medical procedures that are outside of their normal daily clinical practice. All treatment decisions are at the sole discretion of the participating physicians and reflect their current standard of care

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Study Start: 2015-05-31
• Primary Completion: 2017-04-07
• Study Completion: 2017-04-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1743

Inclusion Criteria

• Patient ≥ 18 years of age who has been diagnosed with persistent asthma or patient ≥ 40 years of age and/or (ex)-smoker with more than 10 pack years of smoking who has been diagnosed with COPD
• Treatment with a stable dose (no change in dose or change by less than 50% in the last 3 months) of a Inhaled corticosteroid (ICS), Long-acting beta2-agonists (LABA), Fixed dose combination (FDC) administered twice daily by Dry powder inhaler (DPI) for 3 months prior to enrollment in accordance with its approved indication
• Patient is willing and able to provide written informed consent;
• Patient agrees to participate in the study and to disclose any medical events to the treating physician;
• Patient is able to complete the questionnaires.

Exclusion Criteria

• Current enrolment or planned enrolment in an interventional study (patients are allowed to participate in other observational or case-control studies).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Participants	Marketed antagonists	Patients are confirmed to have either Persistent Asthma or COPD

Primary Outcome Measures

Name	Time	Method
Percentage of patients whose respiratory disease is well controlled	1 Day	Questionnaires capture descriptive, qualitative responses

Secondary Outcome Measures

Name	Time	Method
Most Important Inhaler Features (MIIF) questionnaire	1 Day	MIIF is a 10-point rating scale (where 1 = "not at all easy" and 10 = "extremely easy") for the 5 most important features
Patient Satisfaction Score	1 Day	A 10-point scale (where 1 = "not at all satisfied" and 10 = "extremely satisfied") is used to assess the patients' satisfaction
Percentage of Participants with Adverse Events	3 years
Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8)	1 Day	The 8-item MMAS-8 is a self-reported instrument to measure medication adherence

Trial Locations

Locations (141)

Teva Investigational Site 1011; 🇭🇷 Dubrovnik, Croatia

Teva Investigational Site 1001; 🇭🇷 Karlovac, Croatia

Teva Investigational Site 1007; 🇭🇷 Karlovac, Croatia

Teva Investigational Site 1015; 🇭🇷 Metkovic, Croatia

Teva Investigational Site 1014; 🇭🇷 Pula, Croatia

Teva Investigational Site 1012; 🇭🇷 Rijeka, Croatia

Teva Investigational Site 1005; 🇭🇷 Samobor, Croatia

Teva Investigational Site 1004; 🇭🇷 Sisak, Croatia

Teva Investigational Site 1013; 🇭🇷 Varazdin, Croatia

Teva Investigational Site 1006; 🇭🇷 Zadar, Croatia

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