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| Linda's COPD Clinical Trial Blog |
July 27th
I became interested in clinical trials seven or eight years ago. I had smoked for 38 years of my life. After quitting for six years, I started back. Two years later I was having serious trouble breathing. I feared lung cancer because that is what we hear about most in the warnings about smoking. Then I heard on the radio about a clinical trial for using PET scans to detect lung cancer earlier than commonly used diagnostic methods, such as x-rays or CAT scans. Naturally, I jumped at this opportunity to find out if I had the dreaded disease at the earliest possible moment. I am happy to say I did not, but I did have COPD. My lung capacity was already down to 31 percent of normal for my age and height. I immediately quit smoking and have been faithfully following doctor's orders ever since, trying to regain as much lung function as possible, which at times has been as high as 48 percent of normal.
However, when one has COPD, maintaining enough ability to breathe becomes the primary focus until something happens that seems worse than not being able to breathe, such as losing a child. When that happened to me my FEV1 dropped to 24 percent, requiring the use of oxygen on really bad days. I was able to get off the oxygen but then other issues would knock me out of the box and I'd be back on it. The standard meds such as Advair and Spiriva seemed to have lost their effectiveness and I was using albuterol eight to ten times a day. So when I heard about a new clinical trial for a drug to replace my old standbys, I signed up. That was June 29, 2009.
The clinician told me to stop using my regular albuterol, Advair and Spiriva, and she replaced them with Proair and Qvar. Two weeks later I returned for the lung function tests to see if I qualified. I did. She did not reveal my numbers but I knew they could not be good. I was having to use oxygen every day. I found out the Advair and Spiriva had been doing me more good than I'd realized. On July 23rd I was given the study drug. Twenty-four hours later I no longer needed the oxygen. I am keeping an electronic diary, a small enough requirement for being able to breathe better, plus getting free meds during the study, as well as being paid for the visits. I've had one two-hour visit and one five-hour visit. I go back for my second five-hour visit this week. I'll let you know what happens.
July 30th
Wednesday morning: 7 a.m. wake up call. No coffee, no inhalers, no O2. Surely one cannot be expected to drive in this condition. Well, I did it last week; I can do it again. After showering, I leave the house with wet hair and no makeup, with my meds, food, water, and blankie packed in a tote. I drive the 15 minutes to the clinic, where I am greeted by cheerful, beautifully made-up Monica, who obviously had her coffee this morning...
This second visit is similar to the first: 8 a.m. EKG and lung function testing (LFT), after which I am allowed to eat my breakfast bar, take my meds and drink water. At 10 a.m., I am dosed with study drug. I stretch out on a cold examining table, cover myself with my blankie, and settle down to wait. LFT’s will be repeated three times at intervals of 30 minutes or one hour after dosage.
For this study, lung function testing consists of breathing into a funnel attached to a computer while wearing a nose clip. First are the slow breaths…"Take a deep breath in…let it out slowly."
Next are the fast ones…"Take a deep breath in and blast it out! Blow! Blow! Blow! Hold it… hold it… hold it… just a few more seconds….deep breath IN!"
Whew!
I return to the comfort of the table and blankie and wait until I am called two more times. Next time I will remember to bring a pillow.
The EKG is repeated before the last LFT. Monica checks my nose clip and calls for extra fast ones. I reluctantly oblige. She loads me up with free meds, then tells me I don’t have to come back for a month. This is good news. It will take that long to get my eyeballs back into their sockets.
August 27th
The third visit of the four-month clinical trial on a new drug for COPD began as usual: arrived at 7:45 a.m., no coffee, no inhalers, congested, sleep disturbed, unmade up, with perky Monica poised to take my blood pressure, pulse and weight. This time I remembered to bring my pillow. Stacy, the Director of Clinical Research, came in to question me about how I’ve been feeling, then turned me back over to Monica to start the LFT’s (lung function testing). LFT’s follow the same procedure: slow in and out, then fast in and blow blow blow hold it hold it hold it, breathe in. Ok. I can take a nap. Forty minutes later, the PFT is repeated, then I am “dosed” with whatever is in my canister, study drug or placebo. To keep up appearances, we are still pretending we don’t know if I am on the real thing, but we all know I am because I am feeling so much better. However, a few days later, things took a new turn.
During clinical trials, participants are requested to report any unusual happenings so a determination can be made whether or not to write up such happenings as “adverse events.” Well, wouldn’t you know…
…one morning I awakened at 2 a.m. with the room spinning like one of those round things we played on as kids where you run real fast and push real hard then jump on and ride. Vertigo! I had vertigo!
The spinning stopped once I got to my feet but resumed upon lying down. It never lasted long but was quite frightening. The first thought was brain tumor. The second thought was to let the research coordinator, Betsy, know what was going on. Monica was out that day. Turns out, Betsy has had vertigo also, so it was highly unlikely we both had brain tumors. Furthermore, as she was not on the study drug, it was highly unlikely that my vertigo was related to the trial. However, it still had to be reported just in case other study participants reported vertigo, it would be placed into the literature as an adverse event. She called a few days later to check on me, and I was almost happy to tell her my husband to be, Bill, was having spells of vertigo also. I say happy because the last thing I wanted was for the vertigo to be caused by the study drug. But now that Bill had vertigo we had to get to the bottom of this. Betsy went online and researched causes of vertigo, then called me and asked if we had been exposed to mildew. Jackpot! I’ll skip the story of how Mama flooded the basement before she died. Suffice it to say that everything down there turned to black moldy goo. The Center for Disease Control website lists symptoms that mold can cause. Between Bill and I, we had every one of them: vertigo, eye irritation, skin problems, to name only a few.
Now what?
One dehumidifier, two hospital quality air purifiers, and mold mitigation… that’s what. I never even heard of mold mitigators, now I are one. Actually, not me. I can’t go near the stuff. But someone called a Mold Mitigator has to certify that the mold has indeed been mitigated, or we can never sell this house, and I certainly could not live in it as it was. So $2,000 later, the vertigo and other symptoms have abated. Having Betsy to help me with this is another benefit from participating in this clinical trial.
September 16th
The best part of participating in this particular clinical trial for a new COPD drug, in between blowing into Monica’s infernal machine, has been having nothing to do for five hours a month but nap. The second best part is getting paid for it. I have to qualify that. The very best part has been feeling better because I’ve obviously been getting the study drug, not a placebo.
Very little has been required of me. In between visits I keep an electronic diary, answering the same questions day after day and sending in the answers over the telephone line. It takes about 5 minutes. At first I had to remember to do this, which was causing a problem. But now, every morning at 9:56 a.m. the diary reminds me by beeping twice, every few minutes, until I answer its page. During the visits I have had to fill out a form with a space age pen that Monica inserts into a modem and the computer reads my answers, then prints out the pages. Monica three-hole punches them and places them into a notebook, where my answers await the scientific scrutiny of the pharmaceutical researchers who will decide if this drug is indeed better than what is available now. There is a certain soul satisfaction in that. But when I think of the practical aspects of participation in clinical trials, I have to come back to the money.
In the last blog I wrote about having vertigo, and spending $2,000 to mitigate the mold that had infiltrated my mother’s house. That is a lot of money, especially these days. However, during this trial I have been paid $100 per visit for five visits: $500. I have not had to pay three $38 co-pays per month for 5 months: $570. I am signing up for Phase Two of this same study, where I will make seven more visits during the next year: $700. Plus, I will not have to pay $114 per month co-pays for 12 months: $1,368.
$500
$570
$700
$1,368
$3,138 total compensation for this study.
There is one risk involved in Phase Two. Everyone gets the study drug, but in two different amounts. I don’t know if I will get what I am getting now, or if it will change.
(Other participants would add in the dollars saved by getting free medical care and regular pulmonary function testing. I just happen to have Medicare and a supplement that picks up the co-pays and deductibles for medical care. I highly recommend this type insurance. I hope and pray it does not change because of the fiasco now happening in Washington.)
My pulmonologist is thrilled with how I'm doing. I start the second phase of the drug study next month. It is nice to know that at least seven times next year I will be able to take a nap.
October 28th
So, how do I feel about participating in this particular clinical trial? Right off the bat the first thing that comes to mind is the hardest part of it -- having to leave the house without caffeine and without any sort of lung medication, having to be extra careful during the 20-minute drive to the clinic, then doing those first two LFT’s without any assistance from the study drug. Spirometry before taking the study drug is somewhat tiring. But after one puff from the inhaler device, it has been mostly a matter of resting in between tests, and from time to time during the four hours answering questions posed by the site study staff.
I have been encouraged to report every smidgen of emotional upset, whether caused by something minor, such as dental appointments or the mold contamination in my mother’s house, as described two blogs back, or something as major as the death of my son, mentioned in the first blog. Emotional distress of any type, from any cause, affects breathing; Monica, Betsy and Stacy have shown intense interest in my every mood. It has felt a tad invasive until I’ve realized it is all part of this study, considering how huge an impact emotions have on our overall health. Details about my feelings have been documented and may be revealed to study sponsors and consultants, as necessary. I signed a 19-page consent form to that effect.
Would I do it again? I am doing it again. The last visit of this four-month study was the first visit of the year-long study. There are some differences. In this double-blind study, there are no placebos. We have suspected all along I was not getting a placebo; I’ve done too well. But I do not know which dosage I am receiving. If 200, then I will continue to receive 200. If 400, that will not change. Only participants who were getting a placebo during the four-month trial will be assigned either 200 or 400, decided by the flip of a coin.
During the four-month study I have had to update the electronic diary only once a day, but there were about a dozen questions to be answered. In the year-long the diary will beckon twice a day, but there are only four questions to answer: how many puffs of the study drug (two per day which does not change), and how many puffs of albuterol I take each day, as needed. During the four-month, blood was drawn at the beginning and the end. In the year-long, blood will be drawn each time during the last five visits. ECG’s also will be given at each visit. It is stating the obvious but they are measuring the effects of the medication on my body. And they are interested in whether my body’s need for albuterol as a rescue drug decreases as the length of time on the study drug increases. I guess we will know the answer to that question a year from now.
Oh, and the name of the study drug is Aclidinium Bromide.
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