Status:
TERMINATED
A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was evaluating the effect of reminder notifications and motivational/adaptive messages on treatment adherence behavior in subjects with COPD. The effect will be measured over 24 weeks on th...
Detailed Description
This study was evaluating whether subjects with COPD on Ultibro® Breezhaler® clinical trial formulation once daily dosing regimen using the Concept2 inhaler in conjunction with a patient application c...
Eligibility Criteria
Inclusion
- Signed informed consent
- Have a total adherence of more than 10% but less than or equal to 70% during Screening period
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- A diagnosed COPD
- Taking Ultibro® Breezhaler® for at least 3 month prior to Visit 1
- Have been in the Screening period ≥ 35 days.
Exclusion
- Pregnant or lactating women
- Women of child-bearing potential
- Subjects having a history of reactions/hypersensitivity to inhaled drugs or drugs of a similar class
- Subjects having a history of reactions/hypersensitivity to lactose or any of the other ingredients of trial medication.
- Subjects with relevant concomitant diseases
- Subjects who have had a COPD exacerbation 6 weeks prior to Visit 1 or between V1 and randomization
- Subjects who have had a respiratory tract infection within 3 weeks prior to Visit 1 or between V1 and randomization
- Use of investigational drugs or other investigational devices at the time of enrollment
- Subjects with a preferred inhalation time between 10.00 pm and 2.00 am.
- Subjects taken off Ultibro® Breezhaler® treatment/inhaler use by the investigator during the Screening period for more than 7 days.
- Subjects not returning all Concept2 inhalers received during the Screening period
- Subjects who have demonstrated inability or unwillingness to use the digital system or to fill in questionnaires.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03379233
Start Date
July 11 2018
End Date
January 22 2019
Last Update
January 5 2021
Active Locations (9)
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1
Novartis Investigative Site
Berlin, Germany, 12203
2
Novartis Investigative Site
Hamburg, Germany, 20354
3
Novartis Investigative Site
Hanover, Germany, 30625
4
Novartis Investigative Site
Leipzig, Germany, 04103