Clinical trial NCT01727024: Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
Official title: Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Breezhaler
Respimat
Indacaterol
Tiotropium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-11-15
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Correctly Used the Device at the Start of Handling the Device
timeFrame: day 1
Secondary outcomes:
measure: Number of Participants Correctly Using the Device After One Week of Handling
timeFrame: day 7
measure: Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire
timeFrame: day 7
measure: Number of Participants With Preference for Either Device
timeFrame: day 7
measure: Number of Participnats With Difficulties Experienced When Handling the Devices
timeFrame: 1 week
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Novartis Investigative Site
state: GO
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Florianopolis
country: Brazil
facility: Novartis Investigative Site
state: SC
city: Ribeirao Preto
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Oliveira MVC, Pizzichini E, da Costa CH, Fritscher CC, Vianna EO, Teixeira PJZ, Stirbulov R, Rabahi MF, Pinho NC. Evaluation of the preference, satisfaction and correct use of Breezhaler(R) and Respimat(R) inhalers in patients with chronic obstructive pulmonary disease - INHALATOR study. Respir Med. 2018 Nov;144:61-67. doi: 10.1016/j.rmed.2018.10.006. Epub 2018 Oct 9.