Chronic Obstructive Pulmonary Disease (COPD)Phase 4INHALATORNCT01727024
Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
A Phase 4 study testing Tiotropium and Indacaterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 10 sites in Brazil.
Trial summary
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tiotropium and Indacaterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 10 sitesBrazil
- Study dates
- Apr 2013to Nov 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Previous diagnosis of asthma
- Pregnant or nursing women
- Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30130-100
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-281
Novartis Investigative Site
Florianópolis, Santa Catarina, 88040-970
Novartis Investigative Site
Goiânia, Goiás, 74110-030
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14048-900
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20551-030
Novartis Investigative Site
São Paulo, São Paulo, 01224-000
Novartis Investigative Site
São Paulo, São Paulo, 04039-004
About this study
Official title: Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
- Being tested
- Tiotropium, Indacaterol
- Keywords
- Breezhaler, Respimat, Indacaterol, Tiotropium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
Also called Spiriva®
Tiotropium via Respimat® device once a day
IndacaterolDrug
Also called Onbrez™, Onbrize™
Indacaterol via Breezhaler® device once a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (4)
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.
Measured: day 7
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
Measured: day 7
Number of Participants With Preference for Either Device
Participants answered a single question to determine their device preference.
Measured: day 7
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727024
- Sponsor's protocol ID
- CQAB149BBR02
- Acronym
- INHALATOR
- Status last verified
- Jan 2017
- First submitted
- 12 Sep 2012
- Last updated
- 24 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 30366585
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01727024
- Acronym / sponsor ID
- INHALATOR / CQAB149BBR02
- Keywords
- Breezhaler, Respimat, Indacaterol, Tiotropium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol (QAB149) Breezhaler® | Experimental | Drug: IndacaterolIn 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. |
| Tiotropium Respimat® | Active comparator | Drug: TiotropiumIn 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (3 listed)
- Previous diagnosis of asthma
- Pregnant or nursing women
- Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiotropiumAlso: Spiriva®Tiotropium via Respimat® device once a day | Drug | Tiotropium Respimat® |
| IndacaterolAlso: Onbrez™, Onbrize™Indacaterol via Breezhaler® device once a day | Drug | Indacaterol (QAB149) Breezhaler® |
Primary outcome
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.
4 secondary outcomes
Number of Participants Correctly Using the Device After One Week of Handling
Time frame: day 7
Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire
Time frame: day 7
Number of Participants With Preference for Either Device
Time frame: day 7
Number of Participnats With Difficulties Experienced When Handling the Devices
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30366585Oliveira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tiotropium and Indacaterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 10 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Correctly Used the Device at the Start of Handling the Device (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017; AzTrials last refreshed its copy on 1 Nov 2026.