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

NCT01727024 | Completed Phase 4 Results

• 1 other identifier: CQAB149BBR02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Breezhaler; Respimat; Indacaterol; Tiotropium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Correctly Using the Device After One Week of Handling

  day 7

• Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire

  day 7

• Number of Participants With Preference for Either Device

  day 7

• Number of Participnats With Difficulties Experienced When Handling the Devices

  1 week

Study Arms (2)

Indacaterol (QAB149) Breezhaler®

EXPERIMENTAL

In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.

Drug: Indacaterol

Tiotropium Respimat®

ACTIVE COMPARATOR

In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.

Drug: Tiotropium

Interventions

Tiotropium DRUG

Tiotropium via Respimat® device once a day

Also known as: Spiriva®

Tiotropium Respimat®

Indacaterol DRUG

Indacaterol via Breezhaler® device once a day

Also known as: Onbrez™, Onbrize™

Indacaterol (QAB149) Breezhaler®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous diagnosis of asthma
• Pregnant or nursing women
• Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Goiânia, Goiás, 74110-030, Brazil

Location

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30150-281, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Novartis Investigative Site

Florianópolis, Santa Catarina, 88040-970, Brazil

Location

Novartis Investigative Site

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01224-000, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 04039-004, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30366585 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: November 15, 2012
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 24, 2017
• Results First Posted: January 6, 2017

Record last verified: 2017-01

Locations

BR (10)