CAMPCS/3 Parent Consent Statement
Purpose
You are being asked to consent to your child=s joining the Childhood Asthma Management Program (CAMP) Continuation Study/Phase 3 (CAMPCS/3).
The purpose of this research study is to more completely assess the effects of long-term treatment and other factors on the course of asthma and lung growth into early adulthood. This study will continue through June 2011 (3 2 years). Asthma medications will not be provided to your child during CAMPCS/3 except by your child=s personal asthma care provider.
To qualify for this study, your child must have participated in the CAMP trial.
Procedures
There will be a total of 5 clinic visits during CAMPCS/3: 4 spirometry visits and 1 methacholine visit. The spirometry visits will occur yearly as follows:
Year 1January 1, 2008 - December 31, 20081 spirometry visit
Year 2January 1, 2009 - December 31, 20091 spirometry visit
Year 3January 1, 2010 - December 31, 20101 spirometry visit
Year 4January 1, 2011 - June 30, 20111 spirometry visit
The methacholine visit may take place on any date between July 1, 2008 and June 30, 2011. The spirometry visits in Years 1, 2, and 3 will take place around the anniversary of your child=s enrollment into the CAMP trial. The CAMPCS/3 coordinator can tell you what your child=s visit schedule will be.
At each clinic visit, your child will be asked about symptoms, tobacco smoke exposure, asthma treatment, and home environment since the last visit. Females will be asked about current and past pregnancy.
The procedures your child will complete during CAMPCS/3 are the same ones that your child completed in CAMP.
Your child=s height and weight will be measured at every clinic visit.
At each spirometry visit, your child will complete spirometry before and after bronchodilator (albuterol) as during CAMP. Spirometry is the measurement of the amount of air exchanged between the lungs and the environment during forced vital capacity maneuvers. In the forced vital capacity maneuver, your child will take in the deepest breath possible. Your child will then blow that air out as forcefully as possible until no more air can leave the lungs. The volume of air leaving the lungs is recorded. After approximately 3 blows, 2 puffs of bronchodilator (albuterol) are given from a metered dose inhaler. Spirometry is then repeated. These measurements will help to determine the severity of your child=s asthma and the growth of your child=s lungs.
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CAMPCS/3 Parent Consent Statement (cont'd)
The methacholine challenge is a breathing test which your child completed during CAMP. The test measures how much the airways narrow when methacholine is breathed in. This is called airway responsiveness. The test is being done in CAMPCS/3 because responsiveness can change over time, with age and with treatment. CAMPCS/3 will prepare methacholine solutions using the Provocholine7 brand methacholine chloride powder. This brand of methacholine powder is approved by the United States Food and Drug Administration.
The methacholine test starts with a breathing test, followed by breathing in up to 10 solutions of the methacholine. The breathing test is spirometry. If your child=s lung function is not high enough, the methacholine test will stop. If your child=s lung function is high enough, the test will continue with your child breathing in the first methacholine solution.
The first solution used in methacholine challenge testing contains no methacholine, only saline (salt water) and a preservative (phenol [US clinics] or benzyl alcohol [TOR clinic]) that helps to keep the solution sterile. The second solution contains a very small dose of methacholine (0.098 mg/ml), and each solution that follows contains a larger dose of methacholine than the previous solution. Each of these solutions also contains saline and preservative.
After breathing in the first solution for 2 minutes, your child will do a breathing test (spirometry) to see if there has been any effect. If your child=s airways react to a pre-set level, the test will stop. If the airways do not react to that level, your child will breathe in the next solution, and the breathing test (spirometry) will be repeated. This process will continue until your child=s airways react to the pre-set level or after the 10th solution is given. Thus the dose of methacholine is increased during the test until either the airways react to a pre-set level or the 10th solution is given.
When the methacholine test is stopped, your child will be given a bronchodilator (albuterol) to open the airways if needed (determined by the degree to which your child=s airways reacted to the methacholine). If your child is given a bronchodilator, his/her breathing will be measured after the bronchodilator is used, to be sure that all effects of the methacholine are over. Your child will not be allowed to leave the clinic until breathing has returned to a pre-set level.
We estimate that each spirometry visit will take about 1 hour to complete. We estimate that the methacholine visit will take about 2 hours to complete.
At the end of the study, a dataset will be created and provided to the National Institutes of Health (NIH), the sponsor of CAMPCS/3. The NIH will make this dataset available to other researchers. This dataset will include your child=s study data, but it will not include your child=s name, address, or telephone number.
Risks/discomforts and protections against risks
Lung function tests may cause coughing, wheezing, or shortness of breath. Inhalation of albuterol will be used to relieve any symptoms. Albuterol may cause palpitations, chest pain, rapid heart rate, and tremor or nervousness.
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CAMPCS/3 Parent Consent Statement (cont'd)
Methacholine challenge should not be done in anyone with asthma causing shortness of breath or chest discomfort or wheezing on the day of the test (current clinically apparent asthma) or low lung function. The methacholine challenge will not be done unless your child has adequate lung function; a breathing test is done before the challenge starts to measure and check your child=s lung function on the day of the test.
Methacholine challenge should not be done in anyone who had a bad reaction to other medicines similar to methacholine (parasympathomimetic agents), nor in anyone taking certain heart medicines (beta adrenergic blocking agent) or certain medicines used to treat myasthenia gravis (cholinesterase inhibitors).
Conditions such as epilepsy, cardiovascular disease with bradycardia (slow heart beat), vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction could be adversely affected by a cholinergic agent such as methacholine. If your child has such a condition, a physician must approve your child=s proceeding with the challenge.
Some people have coughing or a tight sensation in their chest from breathing the methacholine, but it is usually mild. However, reactions to methacholine can include severe bronchoconstriction (a severe asthma attack) and loss of respiratory function.
The safety of methacholine during pregnancy and nursing is not known. Females who have reached puberty will be asked to take a pregnancy test if it has been more than 10 days since the last onset of menses.[clinics that are testing all girls who are post menarche will need to alter this sentence] Females who are pregnant and females who are nursing will not do the methacholine challenge test.
Your child=s lung function will be measured before the methcholine test is started and after each solution is breathed in. If your child=s lung function has dropped more than the pre-set level, the test will be stopped. A physician must be available in the clinic during the test (the physician is not required to be in the testing room). Emergency medications and equipment for treating acute respiratory distress must be available when the test is done.
If needed, your child will be given a bronchodilator (albuterol) to open the airways after the methacholine test is stopped. Your child=s lung function will be measured after he/she uses the bronchodilator (spirometry), to be sure that all effects of the methacholine are over.
Benefits
The possible benefits to your child and society from this research study are:
Continuing to observe the children who participated in CAMP into young adulthood will allow us to better understand the outcome of childhood asthma. Also, we will be better able to assess the long-term effects of the CAMP treatments and will be better able to determine what is the best treatment for children with asthma.
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CAMPCS/3 Parent Consent Statement (cont'd)
While your child will receive asthma care from your asthma care provider, the CAMPCS/3 staff will be available for consultation with your asthma care provider. Information collected in CAMPCS/3 on your child=s asthma and growth may be useful to your asthma care provider. If you request it, this information will be given to your asthma care provider after each CAMPCS/3 visit.
Alternatives to Participation
Your and your child=s participation is voluntary. You may choose not to have your child participate in this research study. You may withdraw your consent to your child=s participation at any time. Your choice will not affect the commitment of your health care providers to administer care, and there will be no penalty or loss of benefits to which you or your child are otherwise entitled. There are no alternatives to participation in this study except non-participation in the research.
If, in the future, you withdraw your child from the study, no new study data will be gathered on your child after you withdraw your child. However, data gathered about your child before you withdrew your child will be used.
Rights and Responsibilities
You may withdraw your child from the study at any time and still get care at this institution.
Clinic staff are available to answer any questions or discuss concerns you or your child may have now or in the future.
You will be informed of any significant new findings developed during the course of participation in this research that may affect your willingness to continue in the study or on your child=s health or willingness to continue in the study.
You are responsible for informing clinic staff of changes in your child=s address and telephone number.
Confidentiality
Every effort will be made to keep your child=s records confidential. Our procedures are:
Study data are identified by study ID codes only. Study data are kept in a secure place.
The identity of all study participants is confidential. When the results of this study are published, no data will be listed by name or ID number.
Data important to your child=s medical care may be placed in your child=s medical record at this clinic. Clinical data with name will be released only to you. Clinical data with ID number will be released to the study coordinating center in Baltimore, MD and will be shared with CAMP researchers who analyze and report the study data.
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CAMPCS/3 Parent Consent Statement (cont'd)
As a way to establish and maintain a trusting relationship with your child, we will keep confidential from you any discussions that we have with your child about certain sensitive subjects (such as alcohol or drug use, sexual activities) unless your child permits otherwise, or unless there is a strong compelling medical reason for doing differently.
When the dataset is created for the National Institutes of Health, the study coordinating center will replace your child=s study ID number with a new and arbitrary ID number different from the ID number currently used with your child=s data.
Compensation
You will be reimbursed in the amount of $100 for each visit to the center. [TOR will alter this sentence]
Your and your child=s participation in this research project is completely voluntary. You have the right to withdraw from the research study at any time. You should ask the principal investigator listed below any questions you may have about this research study. You may ask him/her questions in the future if you do not understand something that is being done.
If you think your child has not been treated fairly or think your child has been hurt by joining the study, or you have any other questions about the study, you may call the principal investigator,
[fill in name of principal investigator] at [fill in telephone number], or you may call the [fill in name of IRB for this institution] at [fill in telephone #] . Either the principal investigator or the people in the [fill in name of IRB for this institution] will answer your questions and/or help you find medical care if you feel your child has suffered an injury. The [fill in name of institution] , and the Federal Government do not have any program to provide compensation to you if your child experiences injury or other bad effects which are not the fault of the investigators.
This project has been explained to me, in language that is understandable to me. I have been encouraged to ask questions, both now and in the future, about the research study. I have had the opportunity to have my questions answered. If I have other questions later, I understand that I can contact a study center staff member [name and telephone #] .
If you agree to have your child participate in this study, please sign your name and write the date below.
______
Parent signatureDate of signatureCAMP ID No.
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CAMPCS/3 Parent Consent Statement (cont'd)
______
Witness signatureDate of signature
______
Investigator signatureDate of signature
Note: Signed copies of this consent form must be a) retained on file by the Principal Investigator, b) given to the parent, and c) put in the patient's medical record.
11th grade reading level
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