Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— INHALATOR  

Official title:

Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727024
• Other study ID #: CQAB149BBR02
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2012
• Last updated: January 23, 2017
• Start date: April 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Key Inclusion Criteria:

1. Male and female adults aged =40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure.

2. Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD Guidelines 2010 or grade A in GOLD 2011and including:

• Smoking history of at least 10 pack years

• FEV1/FVC < 70%

Key Exclusion criteria:

1. Previous diagnosis of asthma

2. Pregnant or nursing women

3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium
Tiotropium via Respimat® device once a day
• Indacaterol
Indacaterol via Breezhaler® device once a day

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Florianopolis	SC
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Ribeirao Preto	SP
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Correctly Used the Device at the Start of Handling the Device	The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.	day 1
Secondary	Number of Participants Correctly Using the Device After One Week of Handling	The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.	day 7
Secondary	Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire	Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.; The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction	day 7
Secondary	Number of Participants With Preference for Either Device	Participants answered a single question to determine their device preference.	day 7
Secondary	Number of Participnats With Difficulties Experienced When Handling the Devices	Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.	1 week