COPD III/IV Clinical Trial
Official title:
Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
| Verified date | July 2006 |
| Source | King's College London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a
simple device which has shown, when directed to the patients face, to be effective in
relieving breathlessness.
This phase II trial aims to determine the potential effectiveness of a hand-held fan to
relieve breathlessness over time and to evaluate the recruitment into the study and the
acceptance of the intervention and the control.
The intervention to be tested is a HHF directed to the area of the face innervated by the
second and third trigeminal nerve branches. A wristband was chosen as control under the
assumption that distraction could serve as a placebo.
The main outcomes for this study are uptake into the trial (proportion of patients from the
longitudinal study participating in the RCT), adherence to the study, and use and acceptance
of the intervention and the control. The main outcome for assessing the effect of the
hand-held fan is change of severity of breathlessness between baseline and one month and two
months, respectively.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | February 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions: - Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer) - COPD stage III (severe) and IV (very severe) according to GOLD criteria.[7] Exclusion Criteria: - Unable to provide informed consent - Too ill to be interviewed and not fluent or illiterate in German |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | King's College London | London |
| Lead Sponsor | Collaborator |
|---|---|
| King's College London |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of severity of breathlessness | between baseline and one month | No | |
| Secondary | use and acceptance of the intervention and the control | over 6 months | No | |
| Secondary | adherence to the study | 6 months | No | |
| Secondary | uptake into the trial (proportion of patients from the longitudinal study participating in the RCT) | 18 months | No | |
| Secondary | change of severity of breathlessness | baseline and two months | No |