Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00220753 |
| Other study ID # |
AIR CLEANER TRIAL 2 SIHF |
| Secondary ID |
PARTIAL SPONSOR |
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 19, 2005 |
| Last updated |
July 21, 2009 |
| Start date |
September 2005 |
| Est. completion date |
April 2006 |
Study information
| Verified date |
July 2009 |
| Source |
Sykehuset Innlandet HF |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Norway: Norwegian Social Science Data ServicesNorway: Directorate of Health |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and
pre-set speed functions, have a beneficial effect on patients with asthma and allergy to
dogs.
Air cleaners will be installed in the bedrooms and living rooms in the homes of children and
adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust
mites.
The investigators will look upon the significance of this study, and of a previous study
with a similar design and the same main parameters to find out if this trial supports the
results of the first trial by the same project leader, or makes it likely that the seemingly
beneficial effects of the first study occurred by chance.
Main parameters:
- hyperventilation cold air challenge test
Supportive parameters:
- serum ECP
- symptom scores
The trial will be a parallel, double blind placebo controlled one.
Description:
Project leader: Leif Bjarte Rolfsjord, M.D., section leader, Paediatric Department Sykehuset
Innlandet HF Elverum-Hamar; Ragnhild Halvorsen, M.D. Ph.D., Voksentoppen, Paediatric Clinic,
Rikshospitalet; Leiv Sandvik, Ph.D. professor, research leader statistics, Competence Centre
for Clinical Research, Ullevaal University Hospital
AIM:
To examine if powerful air cleaners with HEPA-filters and a pre-set speed function making it
possible to run the air cleaners at a high, but noisy speed at acceptable times, and , if
wanted, at a lower, but less noisy speed at other times, (Icleen IQAir®) , have a favourable
effect on asthma in children and adolescents aged 8-17 years, who are allergic to dogs, but
not to house dust mite. To look at this study separately, but also look upon the total
results of this study and a previous study performed by the project leader.
BACKGROUND:
The first study is not yet published. We found signs of clinically significant effects of
active air cleaners by the parameters ECP in serum and bronchial hyperreactivity by a cold
air hyperventilation test, but the results gave p-values at the border of statistical
significance, p=0.104 for FEV1 reduction, and significant results, p=0.018 for differences
in the change of ECP. The number of patients included in the study was 49, a lower number
than wanted in the first place. We did not find significant effects on Liz Juniper's Life
Quality Scale scores. Yet, there are reasons to believe that the results of the first study
may have clinical significance. A cold air hyperventilation test reflects a real life
situation in interior parts of Norway, resembling outdoor winter conditions strongly. In the
first study Allergy Control encasing over pillows, eiderdowns and mattresses were applied
compared to placebo, but no signs of effects were found on these children aged 7 to 17 with
allergy to dog or cat, but not to house dust mites. The reason to exclude house dust mite
allergic patients in the first trial was to examine if encasings could have any effect on
patients without house dust mite allergy, and the fact that house dust mite allergy is less
common in Northern interior areas, where the trial took place. Other studies indicate,
however, that air cleaners can reduce allergens from dogs and cats, but not most other
indoor allergens (3). We want to perform a new trial, and publish the results from each
trial in one publication, but also look upon the results of a meta-analysis of both studies.
Our hope is that the two trials can give more reliable information about the effects of the
air cleaners. This time, no dust analyses will be taken, because dust analyses from the
first trial, sent to dr. Susanne Lau at the Charité-Virchow Clinic in Berlin, showed that
the air cleaners removed considerable amounts of dust (personal message from dr. Lau). The
results have been summarised in an article by Groth C et al. in Allergy in 2002, and a
manuscript for an article is now sent to Allergy for publication. The efficiency of IQAir
air cleaners has also been documented by Stiftung Warentest in Germany. Due to limited
resources and the signs of low sensitivity in such a trial, Liz Juniper's Life Quality Scale
will not be applied this time. For economic reasons, hair samples for nicotine analysis will
not be taken this time.
Since the first trial was completed, an important improvement of the air cleaners has
arisen. A new panel makes it possible to pre-set the air cleaners at different speeds or on
and off at different times of the day, at different days of the week. Once a day, the speed
can be changed to another speed or turned off, and once a day, it can be turned back to the
original speed in advance. In addition, the pre-set function can be overridden manually at
any time. In the first trial, the timer on and off function could turn the air cleaners off
once a day and on once a day, with no active cleaning during the timer off intervals, and no
weekday differentiation of the timer. This improvement increases the likelihood that the air
cleaners will be used at higher (and more noisy) speeds at times when nobody is at home,
resulting in lower levels of flying allergen dust levels even at times when people are at
home.
In the first trial, we did not find significantly stronger effects in homes with animals
than in homes without animals. Only a fourth of the homes had animals through the whole
trial period. For this reason, we will only include homes without pets this time, in order
to get a more homogenous population. In the first trial, we had a lower age limit of 7. This
time, the lower age limit is 8, to make it easier for patients to co-operate, avoiding
frustration for seven-year-olds who may be excluded due to co-operation difficulties. The
reason that we require dog allergy this time, not dog or cat allergy as in the first trial,
is that one trial indicates that air cleaners only reduce the amount of airborne cat
allergens marginally if no cat is in the room. This trial was performed in homes with cats
(5). On the other hand, a trial of effects of air cleaners in homes with dogs showed a
significant reduction of dog allergens even in rooms where dogs were not present (1). The
studies are difficult to compare, however, because different dust sampling methods were
applied.
MATERIAL:
30 patients from Hedmark county in south-eastern Norway will be examined for the study at
the start. The patients will be selected from journals of patients having visited the
hospital for asthma during the previous three years, having had verified allergy against
dog, but not house dust mite.
TRIAL DESIGN:
1. Active group: IQAir® air cleaners, one in the patient's bedroom, and one in the room
mostly used by the patient outside the bedroom; with real pre- and main filters.
2. Placebo group: As above, but the main filter substituted by a placebo filter. If the
parents of the child do not live together, and the child visits the other parent at
least every second weekend, both parents will be supplied with air cleaners of the same
type, with equivalent placing of the cleaners.
The air cleaners are labelled either A or B, indicating if they are real or fake. Until
closing of the trial, only the manufacturer will know the code. The patients will be
randomised either to A or B, with no stratification. The air cleaners are sealed. Hence, it
is not possible to open them to see what kind of filters they have, without breaking the
seal. Even the placebo filters will seem real, for people not accustomed to looking inside
air cleaners.
Protocol attachments:
Skin prick tests and specific IgE will only be performed at visit 1. Other examinations and
questions applied at both visits.
ATTACHMENT 1: Clinical examination
Height, weight, inspection of thorax, any stridor must be recorded, respiration frequency,
lung auscultation. The signs recorded after the Kjell Aas scale from P0 to P6:
P0: Normal. P1: No discomfort. Slightly weakened auscultatory ventilation sound. P2: No
discomfort. A few sibili (fine wheezing sounds) or rhonchi at auscultation. Prolonged
audible expirium. No retractions.
P3: No discomfort at rest. Abundant obstructive sounds. Slight jugular retraction, some use
of auxiliary ventilation muscles. Possibly elevated shoulders.
P4: Some discomfort at rest. Abundant obstructive sounds. Fine wheezing heard without
stethoscope. Jugular/intercostal retractions. Use of auxiliary ventilation muscles. Worse
(P5) after cough.
P5: Considerable discomfort at rest. Abundant obstructive sounds. Wheezing expiration.
Wheezing without stethoscope. Energetic use of auxiliary ventilation muscles. Possibly
slight cyanosis.
P6: Alarming obstruction. Often even inspiratory obstruction. NB! Weak respiratory sounds,
but retractions and use of auxiliary muscles and tachypnoea are especially alarming.
Possible cyanosis.
ATTACHMENT 2: Cold air provocation test - method Material
1. Rhes-pro® cold air unit delivering cold air, with a 5.2% CO2 content, to avoid
hypocapnia at hyperventilation. The apparatus must be calibrated to give a standardised
temperature, -15C of the inhaled air at lip level, and 5.2% CO2.
2. Flow volume spirometer with computer.
3. Before the test, one must make sure that there is enough air and CO2 for the unit.
Medication
Drugs that can affect the results must be avoided at a certain interval. In our study, the
following drugs are withheld at the indicated intervals before the test:
- Short acting beta-2-agonist: 12 hours
- Long acting beta-2-agonist: 24 hours.
- Beta-2-agonist slow release oral drugs: Generally not used in our clinic. If yet taken
: 3 days
- Theophylline slow release oral drugs: Generally not used in our clinic. If yet taken: 3
days
- Antihistamines: 7 days
- Leukotriene antagonists: 48 hours.
- Atropine derivatives (ipratropium bromide): 8 hours. After the test, the patient can be
given the rest of his ordinary morning drugs.
Time of the day
1. The test should be performed at the same time every time, preferably in the morning.
2. The patient should rest for 15 minutes before the test, to avoid influence by physical
exercise (bicycling, running up stairs etc.).
Test method
1. Tests performed on Mondays must be avoided to prevent influence by casual contacts and
activities in the course of the weekend before the test.
2. Travels including staying overnight away from the home for more than a week should be
registered, and the test should be performed more than one week after arriving home
from holiday.
3. The patient must have normal clinical signs (P0) before the cold air provocation, or
the test must be postponed.
4. Take flow volume test, best FEV1 out of 3 attempts. A printout of the best spirometry
attempt must be stored in the research archive. The flow volume tests shall be
performed in a sitting position. The patient must use a nose clip during spirometry and
cold air provocation.
5. Provided FEV1 is >70% of predicted, the test is started. If <70%, it is postponed.
6. The air mixture flow is calculated by the pre-provocation best FEV1 value, by
multiplying FEV1 by 20 for children less than 13 years of age at the first visit, and
by 26 for the adolescents more than 13 years of age at the first visit. The patient
remains sitting during the cold air provocation.
7. The patient is instructed to breathe rapidly and deeply through the mouthpiece during
the provocation, which lasts for 4 minutes. In practice, the test is performed by
letting the child breathe sufficiently to keep a connected balloon or ventilation bag
halfway filled.
8. Spirometry with FEV1 must be performed straight before and 2 minutes after provocation.
9. MEF50 (=FEF50) at each spirometry being recorded as the spirometry giving the best FEV1
will be registered.
10. Auscultation signs immediately before each series of three spirometry attempts, and
possible cough, will be registered.
11. After the post-provocation spirometry (two minutes after the provocation), salbutamol,
Ventolin 0,1mg meter dose inhaler by Volumatic will be given for reversibility test; 2
puffs for patients weighing less than 45 kg, and 4 puffs for patients weighing 45 kg
and more; one puff at a time; 5 inhalations per puff. New spirometry will be performed
5 minutes after giving Ventolin, and FEV1 is registered again, in absolute value, and
percentage of the first value, before cold air provocation.
12. Even if the risk for acute severe asthmatic symptoms is low, a nebuliser for giving
salbutamol and adrenaline for subcutaneous injection and equipment for intravenous
administration of antiasthmatic drugs will be easily available.(The treatment scheme
from the Norwegian Paediatric Association's acute therapy book will be applied.)
Evaluation of the test results Percentage fall in FEV1 and FEF50 will be applied as a
parameter of bronchial reactivity. More than 10% fall in FEV1 after cold air or more
than 10% rise in FEV1 after inhalation of Ventolin, is considered significant.
Printouts of the spirometry results will be saved. Patient registration sheet cold air
hyperventilation test (Printouts from spirometry to be attached).
The following data will be noted:
Time of day, hours, minute. Height (cm) Weight (kg) Assisted by (nurse) Assisted by
(doctor).
Questions to be asked:
Staying away from home for more than 2 weeks last month or during trial? Staying overnight
away from home last week? Staying overnight for more than a week, less than one week ago?
Inhaled drugs - Ventolin, Serevent, Flutide, doses, numbers of hours ago. Other drugs, route
Dose x times a day Last dose, number of hours ago
To be recorded from spirometry:
Best FEV1 (pre-test) litres per minute Temperature at mouthpiece: (will be held at -15 °C).
Air flow in cold unit (litres per minute) CO2 flow in cold unit (litres per minute) Number
of minutes of provocation Number of pauses Patient's performance will be recorded as good,
acceptable or unacceptable.
The following values and signs noted before provocation, 2 minutes after provocation and 5
minutes after Ventolin given in a spacer (Volumatic®).
FEV1, FEV1 % increase (+) or decrease (-) of pre-test MEF50 MEF50 % of first Aas score
(P0-P6) Cough Other signs or symptoms If other rescue medication is given than Ventolin in
Volumatic, it must be noted.
ATTACHMENT 3: Inquiry about animal contact.
1. Are there pets in the home?
2. Did you react by nose symptoms, sneezing, cough or breathing difficulties the last time
you were close to a dog without having taken drugs against asthma or allergy?
3. What kind of pet do you have in the home:
If animal removed the last half year, how many months ago? Animal now? Number of
animals? Specify if you have cat, dog, rabbit, hamster, other furred pets, budgerigar,
other birds, fish, other animals
4. Are you (patient) in contact with animals outside the home? How often; what kind of
animal? ATTACHMENT 4: Inquiry about smoking. The staff fill in questions to patient if
the patient, or anybody else in the home smokes, and if smoking in the home totals less
than 10, 10-20, or more than 20 cigarettes a day.
ATTACHMENT 5: Questions about fitted carpets, humidity, vacuum cleaners, mechanical
ventilation systems.
The following questions are asked by staff to parent or accompanying person (what person
will be recorded).Filled in together with:
1. Do you have fitted carpets?
2. Do you have fitted carpets in the child's bedroom?
3. Do you have fitted carpets in the living room?
4. Do you have fitted carpets in other rooms?
5. Do you think that you have more than 5 cm of dew or frost on the inside of the window
of the child's bedroom?
6. Is there any smell of mould in your house?
7. Where in the house is there a smell of mould?
8. Can you see mould or rotten patches in any room?
9. If yes, where can you see it?
10. What kind of vacuum cleaner do you have?
11. Is there, except for ventilation over the kitchen stove, any kind of mechanical
ventilation or air filtration in the home? ATTACHMENT 6: Symptom score The patients are
asked to draw a circle around one of the numbers, from 1 through 5, indicating the
degree of symptoms, 1 meaning no or never, 5 meaning many times each night, severe,
always, cannot breathe through my nose or cannot breathe through my nose while sitting
still, respectively. For patients taking antihistamines, the nose symptoms are valid
for the last 5 days. Otherwise, the questions are applicable to the last month.
Questions to patients at Visit 1 Sep./Oct.-05:
1. Do you wake up at night due to asthma?
2. How is your asthma during daytime?
3. Do you feel your asthma when you run?
4. Is your nose stuffy at night? To patients who have taken antihistaminic agents
regularly for the last month this question will be asked instead: Has your nose been
stuffy in daytime for the last 5 days?
5. Is your nose stuffy during daytime? To patients who have taken antihistaminic agents
regularly for the last month this question will be asked instead: Has your nose been
stuffy in daytime for the last 5 days? Finally, a question is asked about strong asthma
attacks last 3 months. Options for answers ar no, once or several times.
ATTACHMENT 7: Medication. Prophylactic medication will be kept constant during the trial.
Doubling doses of inhaled steroids for maximum two weeks during exacerbations or airway
infections, or, in patients not taking inhaled steroids daily, taking inhaled steroids for
maximum two weeks during exacerbations or airway infections, will be accepted. Systemic
corticosteroids in the trial period will lead to exclusion.
Ongoing medication: See section about cold air challenge (attachment 2)
Pre-trial medication:
Date prescribed or "1-3" (between 1 and 3 months ago) or ">3" (more than 3 months ago) Drug
name Total amount of doses prescribed Generic name Drug type (tablets, oral mixture,
injection liquid etc.) Administration route Amount per dose Measured as (ml, mg etc.) Times
a day in good periods Times a day in bad periods or prodromal stages Max. duration of
increased dose in days Date taken away
Medication prescribed in trial period:
Date prescribed Prescribed by Drug name Total amount of doses prescribed Generic name Drug
type(tablets, oral mixture, injection liquid etc.) Administration route Amount per dose
Measured as (ml, mg etc.) Times a day in good periods Times a day in bad periods or
prodromal stages Max. Duration of increased dose in days Date taken away ATTACHMENT 8: Skin
prick tests The skin prick tests are performed with a lancet with a one mm tip (ALK). All
the tests will be performed in duplicate according to the EAACI Position paper i.e. the
tests will be placed in a mirror fashion on the volar aspect of the forearm. The reactions
will be read after 15 minutes. The weals are to be circumscribed by a fine filter pen or
ballpoint pen on the red skin around the weal, near the weal edge. A transparent tape strip
is to be pressed over the circumscription and transferred over to the registration sheet.
The weal size is to be recorded by assessment of the average weal diameter. Weals with an
average diameter >3 mm will be considered positive.
Skin prick test protocol - allergen extract solutions and reference solutions Skin prick
tests shall be performed at the inclusion of the patients at visit 1, Sep./Oct.-05.
Soluprick® extract solutions from ALK will be applied.
Specifications:
1. Birch: Soluprick® SQ "ALK Abello" (108) Silver birch 10 HEP
2. Timothy: Soluprick® SQ "ALK Abello" (225) Timothy grass 10 HEP
3. Mugwort: Soluprick® SQ "ALK Abello" (312) Mugwort 10 HEP
4. House dust mite: Soluprick® SQ "ALK Abello" (504) D. Farinae 10 HEP
5. House dust mite: Soluprick® SQ "ALK Abello" (503) D. Pteronyssin. 10 HEP
6. Mould: Soluprick® SQ "ALK Abello" (417) Cladosporium herbarum 1:20 w/v
7. Mould: Soluprick® SQ "ALK Abello" (402) Alternaria alternata 1:20 w/v
8. Dog: Soluprick® SQ "ALK Abello" (553) Dog hair 10 HEP
9. Cat: Soluprick® SQ "ALK Abello" (555) Cat hair 10 HEP
10. Horse: Soluprick® SQ "ALK Abello" (552) Horse hair 10 HEP Soluprick® "ALK Abello"
Negative Control will be used as negative control, and Soluprick® "ALK Abello" Positive
Control, histamine dihydrochloride 10 mg/ml (ALK) as positive control.
ATTACHMENT 9 - SPECIFIC IGE A blood sample is to be taken at visit 1 in Sep/Oct.-05, for
specific IgE for the same allergens as the skin prick tests, except for D.pteronyssinus.
Reagents from Pharmacia Diagnostics will be applied, and their procedures for blood sampling
and analyses will be applied. EMLA "Astra-Zeneca" cream can be used if wanted as a topic
anaesthetic agent before blood sampling.
ATTACHMENT 10 - serum ECP At both visits, blood samples will be taken for serum ECP.
Reagents from Pharmacia Diagnostics will be used, and their manuals for blood sampling and
analyses applied.
