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Completed

NCT Number: NCT01727024

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Goiânia, Goiás, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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%

Key Exclusion criteria:

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

Treatment and study plan

Tiotropium

Drug

Tiotropium via Respimat® device once a day

Other names: Spiriva®

Indacaterol

Drug

Indacaterol via Breezhaler® device once a day

Other names: Onbrez™, Onbrize™

Primary outcomes

  1. Number of Participants Who Correctly Used the Device at the Start of Handling the Device

    Time frame: day 1

    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.

Secondary outcomes

  1. Number of Participants Correctly Using the Device After One Week of Handling

    Time frame: day 7

    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.

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

    Time frame: day 7

    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

  3. Number of Participants With Preference for Either Device

    Time frame: day 7

    Participants answered a single question to determine their device preference.

  4. Number of Participnats With Difficulties Experienced When Handling the Devices

    Time frame: 1 week

    Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: INHALATOR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2012
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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