Trial Outcomes & Findings for Intervention to Improve Inhalative Adherence (NCT NCT02386722)

NCT ID: NCT02386722

Last Updated: 2025-03-04

Results Overview

The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation".

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 169 participants
• Primary outcome timeframe: 182 days
• Results posted on: 2025-03-04

Participant Flow

Patients from several hospitals in the Basel region and patients treated by pulmonologists in private practice are screened for eligibility. In addition, advertisement is made using posters, flyers, as well as on ad-screens. Advertisement is also placed in local newspapers. Enrolment started on January 2014 and will ended on September 2017.

Prior to randomization, all participants take part in a training course before the baseline visit. The goal of the training course is to provide refresher training on inhalation techniques in order to ensure that all participants are at the same level of disease knowledge and use their medication correctly.

Participant milestones

Measure	Intervention Group The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Overall Study STARTED	84	81
Overall Study COMPLETED	75	74
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control Group n=74 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.	Intervention Group n=75 Participants Patients were randomly assigned either to the intervention or control group. The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS. Smartinhaler/POEMS with audio reminders and additional support calls: Patients assigned to the intervention group will receive a Smartinhaler/POEMS, which will contain an audio reminder function. If the alarm function is on, a ring tone will be generated, after the time predesigned for inhalation. If the use of	Total n=149 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 8.8 • n=74 Participants	64.7 years STANDARD_DEVIATION 12.4 • n=75 Participants	68.1 years STANDARD_DEVIATION 8.4 • n=149 Participants
Sex: Female, Male Female	23 Participants n=74 Participants	29 Participants n=75 Participants	52 Participants n=149 Participants
Sex: Female, Male Male	51 Participants n=74 Participants	46 Participants n=75 Participants	97 Participants n=149 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 182 days

The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation".

Outcome measures

Measure	Intervention Group n=75 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=74 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Time to Next Asthma or COPD Exacerbation up to 182 Days	172 days to first exacerbation Interval 161.0 to 182.0	161 days to first exacerbation Interval 149.0 to 174.0

SECONDARY outcome

Timeframe: 180 days

Number of exacerbations during the study period.

Outcome measures

Measure	Intervention Group n=75 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=74 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Number of Exacerbations.	0.3 number of exacerbations Standard Deviation 0.6	0.5 number of exacerbations Standard Deviation 1.0

SECONDARY outcome

Timeframe: 180 days

Exacerbations with the need for hospitalization.

Outcome measures

Measure	Intervention Group n=75 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=74 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Number of Severe Exacerbations.	0.08 severe exacerbations Standard Deviation 0.3	0.08 severe exacerbations Standard Deviation 0.4

SECONDARY outcome

Timeframe: 180 days

Mean duration with Adherence to Puff Inhalers in the Target Range

Outcome measures

Measure	Intervention Group n=57 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=60 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Adherence to Puff Inhalers	81.6 days in target range Standard Deviation 14.2	60.1 days in target range Standard Deviation 30.3

SECONDARY outcome

Timeframe: 180 days

percentage of days with Adherence to Dry Powder Capsules. Taking adherence = [number of puffs inhaled during 24 hours / number of puffs prescribed during 24 hours) x 100. Correct taking adherence was considered when taking adherence was between 80-100%, based on previous studies.

Outcome measures

Measure	Intervention Group n=41 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=49 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS	89.6 % of days in target range Standard Deviation 9.8	80.2 % of days in target range Standard Deviation 21.3

SECONDARY outcome

Timeframe: 180 days

percentage of days of Adherence for puff inhalers (metered dose inhalers, Turbohaler, Discus, Ellipta) assessed by Smartinhalers.

Outcome measures

Measure	Intervention Group n=57 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=60 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Percentage of Days of Adherence	68.9 % of days in target range Standard Deviation 25.0	50.6 % of days in target range Standard Deviation 32.5

SECONDARY outcome

Timeframe: 180 days

percentage of days with timing Adherence for dry powder capsules (Breezhaler, Handihaler), assessed by POEMS

Outcome measures

Measure	Intervention Group n=41 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=49 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Percentage of Days With Timing Adherence	79.6 % of days in target range Standard Deviation 12.9	71.7 % of days in target range Standard Deviation 22.0

SECONDARY outcome

Timeframe: 180 days

Percentage of Gaps in Puff Inhaler Use Gaps = [number of days without inhalation during the whole study period / number of days in same time period] x 100.

Outcome measures

Measure	Intervention Group n=57 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=60 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Percentage of Gaps in Puff Inhaler Use	3.2 % of gaps Standard Deviation 4.7	11.7 % of gaps Standard Deviation 18.6

SECONDARY outcome

Timeframe: 180 days

Percentage of Gaps = [number of days without inhalation during the whole study period / number of days in same time period]

Outcome measures

Measure	Intervention Group n=41 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=49 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS.	4.6 % gaps Standard Deviation 4.4	9.8 % gaps Standard Deviation 8.9

SECONDARY outcome

Timeframe: 180 days

Maximal gap length = number of consecutive days of the longest period of time without Inhalation during the investigated timeperiod.Assessed by Smartinhalers.

Outcome measures

Measure	Intervention Group n=57 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=60 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period	1.6 days Standard Deviation 2.0	11.6 days Standard Deviation 25.6

SECONDARY outcome

Timeframe: 180 days

Maximal gap length for dry powder capsules (Breezhaler, Handihaler), Assessed by POEMS = number of consecutive days of the longest period of time without inhalation.

Outcome measures

Measure	Intervention Group n=41 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=49 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Number of Days of the Longest Period of Time Without Inhalation.	2.6 days Standard Deviation 2.7	5.9 days Standard Deviation 5.2

SECONDARY outcome

Timeframe: 180 days

Score of the St. George Respiratory Questionnaire. Quality of life was assessed using the St. George Respiratory Questionnaire. This is a questionnaire, which was developed for measuring impaired health and perceived well-being in patients with asthma and COPD. Each Subscore ranges from 0-100, higher scores indicate more limitations in one of the 4 domains.

Subscore Symptoms (ranges from 0-100): higher scores indicate worse outcome Subscore Activity (ranges from 0-100): higher scores indicate worse outcome Subscore Impact (ranges from 0-100): higher scores indicate worse outcome

Total Score (ranges from 0-100): higher scores indicate worse outcome. The total score is calculated as a weighted sum of the three subscores. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100.

Outcome measures

Measure	Intervention Group n=75 Participants The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participant's smartphones. In addition, patients in the intervention group received support calls carried out by the pharmacist, when the use of rescue medication doubled respectively when the inhaled medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback from the pharmacist on their adherence at each clinical visit, especially for the results of the POEMS.	Control Group n=74 Participants Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. The alarm function of the devices will be switched off, and these participants will not be reminded to take their inhalers. This group will not receive any calls, if they do not comply with the prescribed medication schedule or if they use their rescue medication too frequently.
Score of the St. George Respiratory Questionnaire Subscore Symptoms	45.7 score on a scale Standard Deviation 21.5	48.7 score on a scale Standard Deviation 25.6
Score of the St. George Respiratory Questionnaire Subscore Activity	45.2 score on a scale Standard Deviation 19.3	52.4 score on a scale Standard Deviation 23.7
Score of the St. George Respiratory Questionnaire Subscore Impact	21.8 score on a scale Standard Deviation 14.6	29.3 score on a scale Standard Deviation 20.7
Score of the St. George Respiratory Questionnaire Total Score	32.5 score on a scale Standard Deviation 14.7	39.6 score on a scale Standard Deviation 20.3

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Claudia Gregoriano

Cantonal Hospital Baselland

Phone: +41619253765

Email: claudia.gregoriano@ksbl.ch

Results disclosure agreements

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