Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Breezhaler, Respimat, Indacaterol, Tiotropium
Brief summary
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
Interventions
DRUGTiotropium
Tiotropium via Respimat® device once a day
DRUGIndacaterol
Indacaterol via Breezhaler® device once a day
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Correctly Used the Device at the Start of Handling the Device | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Correctly Using the Device After One Week of Handling | 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. |
| Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire | 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 |
| Number of Participants With Preference for Either Device | day 7 | Participants answered a single question to determine their device preference. |
| Number of Participnats With Difficulties Experienced When Handling the Devices | 1 week | Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed. |
Countries
Brazil
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All participants who were randomized either to sequence 1 or sequence 2 | 140 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Lost to Follow-up | 1 | 1 |
| Period 1 | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 63.5 Years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 136 | 11 / 134 |
| serious Total, serious adverse events | 0 / 136 | 0 / 134 |
Outcome results
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.
Time frame: day 1
Population: The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indacaterol (QAB149) Breezhaler® | Number of Participants Who Correctly Used the Device at the Start of Handling the Device | 55 Participants |
| Tiotropium Respimat® | Number of Participants Who Correctly Used the Device at the Start of Handling the Device | 49 Participants |
p-value: 0.451Generalized Estimating Equation (GEE)
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
Time frame: day 7
Population: The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol (QAB149) Breezhaler® | Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire | 46.0 score on a scale | Standard Deviation 5.7 |
| Tiotropium Respimat® | Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire | 44.4 score on a scale | Standard Deviation 6.4 |
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.
Time frame: day 7
Population: The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indacaterol (QAB149) Breezhaler® | Number of Participants Correctly Using the Device After One Week of Handling | 93 Participants |
| Tiotropium Respimat® | Number of Participants Correctly Using the Device After One Week of Handling | 81 Participants |
Secondary
Number of Participants With Preference for Either Device
Participants answered a single question to determine their device preference.
Time frame: day 7
Population: The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol (QAB149) Breezhaler® | Number of Participants With Preference for Either Device | Breezhaler® | 76 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participants With Preference for Either Device | Respimat® | 40 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participants With Preference for Either Device | Indifferent | 17 Participants |
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.
Time frame: 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Unpractical | 0 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Felt that capsule was out of place | 1 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Sometime vibration of drug was not heard | 1 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Anxiety | 0 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Placing capsule and inhaling drug | 1 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Capsule sticks to contact when hand is wet/moist | 1 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Requiring aspiration of drug more than once | 1 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Difficulty turning the device | 0 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Difficulty emptying the capsule in 1 aspiration | 1 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Difficulty using the device | 0 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Unable to place the capsule in the device | 1 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | Patient reported to be unable to place the capsule | 0 Participants |
| Indacaterol (QAB149) Breezhaler® | Number of Participnats With Difficulties Experienced When Handling the Devices | More difficulty handling this device than previous | 0 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Unable to place the capsule in the device | 0 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Unpractical | 1 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Difficulty turning the device | 1 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | More difficulty handling this device than previous | 1 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Sometime vibration of drug was not heard | 0 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Difficulty emptying the capsule in 1 aspiration | 0 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Anxiety | 1 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Patient reported to be unable to place the capsule | 1 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Placing capsule and inhaling drug | 0 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Difficulty using the device | 1 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Capsule sticks to contact when hand is wet/moist | 0 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Felt that capsule was out of place | 0 Participants |
| Tiotropium Respimat® | Number of Participnats With Difficulties Experienced When Handling the Devices | Requiring aspiration of drug more than once | 0 Participants |