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This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | Tiotropium via Respimat® device once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire |
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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:
Key Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Goiânia | Goiás | 74110-030 | Brazil | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30366585 | Derived | 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. |
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Total number of participants randomized to the study was 140. However, one participant did not meet an exclusion criterion. Therefore, the starting numbers in the participant flow reflect the 139 eligible randomized participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol Breezhaler® First, Then Tiotropium Respimat® | 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. |
| FG001 | Tiotropium Respimat® First, Then Indacaterol Breezhaler® | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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The analysis population contained all 140 participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All participants who were randomized either to sequence 1 or sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed. | Posted | Number | Participants | day 1 |
|
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A total of 138 participants received at least one treatment (Respimat or Breezhaler). Two patients received only Respimat and didn't receive Breezhaler. (safety population of breezhaler was 136) and 4 patients received only Breezhaler and didn't receive Respimat (safety population of Respimat was 134).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indacaterol (QAB149) Breezhaler® | Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| C510790 | indacaterol |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Indacaterol | Drug | Indacaterol via Breezhaler® device once a day |
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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 |
| Number of Participants With Preference for Either Device | Participants answered a single question to determine their device preference. | 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. | 1 week |
| Belo Horizonte |
| Minas Gerais |
| 30130-100 |
| Brazil |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | 30150-281 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Novartis Investigative Site | Florianópolis | Santa Catarina | 88040-970 | Brazil |
| Novartis Investigative Site | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01224-000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04039-004 | Brazil |
| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
|
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| 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. | The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed. | Posted | Number | Participants | day 7 |
|
|
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| 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 | The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed. | Posted | Mean | Standard Deviation | score on a scale | day 7 |
|
|
|
| Secondary | Number of Participants With Preference for Either Device | Participants answered a single question to determine their device preference. | The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed. | Posted | Number | Participants | day 7 |
|
|
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| 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. | The safety analysis set, which included participants who received at least one dose of study medication, was considered for the analysis. However, only participants who had observed values, were analyzed. | Posted | Number | Participants | 1 week |
|
|
|
| 0 |
| 136 |
| 7 |
| 136 |
| EG001 | Tiotropium Respimat® | Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days. | 0 | 134 | 11 | 134 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain uppper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Saliva altered | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| Title | Measurements |
|---|---|
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| Placing capsule and inhaling drug |
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| Capsule sticks to contact when hand is wet/moist |
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| Requiring aspiration of drug more than once |
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| Difficulty turning the device |
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| Difficulty emptying the capsule in 1 aspiration |
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| Difficulty using the device |
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| Unable to place the capsule in the device |
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| Patient reported to be unable to place the capsule |
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| More difficulty handling this device than previous |
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| Unpractical |
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| Felt that capsule was out of place |
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