Trial Outcomes & Findings for Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients (NCT NCT01727024)

Last Updated: 2017-01-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

day 1

Results posted on

2017-01-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Period 1 STARTED	71	68
Period 1 COMPLETED	68	64
Period 1 NOT COMPLETED	3	4
Period 2 STARTED	68	64
Period 2 COMPLETED	68	64
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Period 1 Lost to Follow-up	1	1
Period 1 Withdrawal by Subject	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=140 Participants All participants who were randomized either to sequence 1 or sequence 2
Age, Continuous	63.5 Years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Indacaterol (QAB149) Breezhaler® n=136 Participants Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.	Tiotropium Respimat® n=135 Participants Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
Number of Participants Who Correctly Used the Device at the Start of Handling the Device	55 Participants	49 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Indacaterol (QAB149) Breezhaler® n=135 Participants Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.	Tiotropium Respimat® n=134 Participants Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
Number of Participants Correctly Using the Device After One Week of Handling	93 Participants	81 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Indacaterol (QAB149) Breezhaler® n=135 Participants Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.	Tiotropium Respimat® n=134 Participants Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire	46.0 score on a scale Standard Deviation 5.7	44.4 score on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: 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.

Participants answered a single question to determine their device preference.

Outcome measures

Outcome measures
Measure	Indacaterol (QAB149) Breezhaler® n=133 Participants Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.	Tiotropium Respimat® Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
Number of Participants With Preference for Either Device Breezhaler®	76 Participants	—
Number of Participants With Preference for Either Device Respimat®	40 Participants	—
Number of Participants With Preference for Either Device Indifferent	17 Participants	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Indacaterol (QAB149) Breezhaler® n=135 Participants Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.	Tiotropium Respimat® n=134 Participants Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
Number of Participnats With Difficulties Experienced When Handling the Devices Difficulty emptying the capsule in 1 aspiration	1 Participants	0 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Difficulty using the device	0 Participants	1 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Sometime vibration of drug was not heard	1 Participants	0 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Anxiety	0 Participants	1 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Placing capsule and inhaling drug	1 Participants	0 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Capsule sticks to contact when hand is wet/moist	1 Participants	0 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Requiring aspiration of drug more than once	1 Participants	0 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Difficulty turning the device	0 Participants	1 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Unable to place the capsule in the device	1 Participants	0 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Patient reported to be unable to place the capsule	0 Participants	1 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices More difficulty handling this device than previous	0 Participants	1 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Unpractical	0 Participants	1 Participants
Number of Participnats With Difficulties Experienced When Handling the Devices Felt that capsule was out of place	1 Participants	0 Participants

Adverse Events

Indacaterol (QAB149) Breezhaler®

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Tiotropium Respimat®

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Indacaterol (QAB149) Breezhaler® n=136 participants at risk Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.	Tiotropium Respimat® n=134 participants at risk Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/136 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).	0.75% 1/134 • Number of events 1 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).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/136 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).	0.75% 1/134 • Number of events 1 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).
Cardiac disorders Palpitations	0.00% 0/136 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).	0.75% 1/134 • Number of events 1 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).
Nervous system disorders Headache	0.74% 1/136 • Number of events 1 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).	0.75% 1/134 • Number of events 1 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).
Nervous system disorders Dizziness	0.74% 1/136 • Number of events 1 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).	0.75% 1/134 • Number of events 1 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).
Nervous system disorders Dysgeusia	0.74% 1/136 • Number of events 1 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).	0.00% 0/134 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).
Gastrointestinal disorders Abdominal pain uppper	0.74% 1/136 • Number of events 1 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).	0.00% 0/134 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).
Gastrointestinal disorders Odynophagia	0.00% 0/136 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).	0.75% 1/134 • Number of events 1 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).
Nervous system disorders Saliva altered	0.00% 0/136 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).	0.75% 1/134 • Number of events 1 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).
Respiratory, thoracic and mediastinal disorders Cough	0.74% 1/136 • Number of events 1 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).	0.75% 1/134 • Number of events 1 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).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/136 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).	0.75% 1/134 • Number of events 1 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).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.74% 1/136 • Number of events 1 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).	0.00% 0/134 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).
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/136 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).	1.5% 2/134 • Number of events 2 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).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/136 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).	0.75% 1/134 • Number of events 1 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).
Infections and infestations Nasopharyngitis	0.74% 1/136 • Number of events 1 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).	0.00% 0/134 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).