Thursday, 5 November 2015 You may recall that on days 2, 3 and 4 of taking QBW251 I started to have some form of effect in one way or the other.
Whether this was side effects such as feeling sick or having headaches or other effects such as having the feeling my sinuses were more clear and able to breath better whilst exercise, this gave me some form of indication the drug was doing its job…or maybe a coincidence? Who knows?
Now today (day 17 into the trial; day 3 of coming off QBW251), I’ve started to have effects as the drug is making its way out of my body.
I noticed a slight increase in coughing in particular first thing in the morning.
Day 20 (Sunday, 8 November 2015) Today I’ve been to the gym to do a chest workout. Breathing is as normal as it was when on QBW251.
Is this an indication the drug is still active in my body?
Could it be that in the last month I’ve simply become stronger and the effect of the drug be a coincidence?
I have 2 more visits to the hospital in regards to the trial:
Day 28 (Monday, 16 November 2015)
Day 42 (Monday, 30 November 2015)
And then…drums rolling here…3-4 months after the final date, I will know whether or not I had the placebo and results of the various tests I’ve had during my 42 days.
Today I had an appointment at Wythenshawe Hospital in regards to the drug trial.
The sad part of today is that it’s the last day I’m on QBW251.
However, this doesn’t mean I’m at the end of the trial. I still have to return on day 28 and 42 for further tests…I’m guessing to see changes in the body as the drug leaves the system.
Weight: 68.3kg (up by 1.2kg since last Monday).
I’ve gained since 18 March 2015 6.1kg (1 stone)…amazing.
This morning a repeat of some screening tests as followed:
Sweat chloride assessment
With blood sampling, they had to take blood pre-dose and 2 hours post-dose.
Again they managed to take the first lot of blood first time. Yay!
However, I’m yet to wait if the second lot of blood will be taken without a glitch.
An interesting comment made about the drug is although the tests will help see how my body reacts to the drug as it enters the system, no change in lung function doesn’t necessarily mean the drug isn’t doing its job. There could be a chance I’ve simply not been on the drug long enough for it to have an effect on lung function.
It will be strange not having the drug after my last dose tonight. However, I am looking forward to “what happens next”.
I would say this isn’t the end of the story, but the beginning.
This isn’t an attack on anybody, nor should this be used as an attack.
Someone made a comment about whether or not I should quiet things down on the publishing front about the trial of QBW251 in case it turns out I’ve created all this hype when it could be I’m on the placebo.
Although I can see where they are coming from, what I highlighted was I made it clear from the beginning nobody knows if I’m on the drug or placebo.
All I can do is guess merely by the effects the drug is having that I could possibly well be on the actual drug.
Although there is a 50% chance I’m wrong, I have felt subtle changes since I started this trial, which could indicate I am not on the placebo.
Whether I am correct or this is by chance is another matter.
The fact the trial is ongoing to me is the main thing.
Whether or not I’m on the placebo doesn’t matter. It’s an unknown journey for me and I love sharing this journey with you all.
We all know there are drugs out there already for other genotypes doing the same work.
What we need to do is raise awareness about Cystic Fibrosis, its effects on the CF community and the importance this trial will have on our lives.
It’s about time CF got exposed as it seems to be something not enough people know about.
DAY 2 (Wednesday, 21 October 2015) Well, so far I’ve had no side effects or any other effects from the drug…though there’s still time.
This was the first thought of today. However as the day passed, things started to happen. Whether a coincidence was another question.
At 11:20am I had a sensation in my lungs and sinuses as though they were clearing themselves more. I could feel what felt like thick mucus making its way up and out. However, I chose to remain sceptical, though thought it was worth noting as feedback for my next study trail visit.
I was in the CF clinic at 2:00pm. All is looking good. Effect of the drug hasn’t shown in lung function. Though it’s early days yet. The drug will probably take approx 4 days before effects, if any, are noticed. Whether I will notice them without tests or not is yet to be known.
I talked with the Doctor about the Kalydeco video I shared in an earlier post. I mentioned to him that over the years of being asked what CF is, I found it hard to put into words what it’s all about. However having watched the video, this made CF so easy to understand and for me to describe the basic function that I’m surprised a drug like this hasn’t been found much much sooner. This made the Doctor laugh.
Obviously had the human body been mechanical, switching on the faulty gene would be a lot easier.
DAY 3 (Thursday, 22 October 2015) At 9:10am felt a little sick, which lasted approximately 3 hours…maybe a coincidence, but this is one of the side effects of taking QBW251.
No other side effects were experienced.
DAY 4 (Friday, 23 October 2015) Weight 65.7kg.
The staff found it astonishing that I was able to take 6 tablets in 1 go.
When I said I’m used to swallowing a good mouthful, they started laughing. People have such filthy minds when they’re around me! LOL
At 11:50am whilst at work, I started to feel a little sick again like yesterday.
At 1:50pm I started with a mild headache – another known side effect. Followed 5 minutes later with slight dizzy feelings.
Again maybe a coincidence, but today I’ve had 3 different known side effects to the drug.
Whether signs this is THE drug or is the placebo and a coincidence is another matter.
9:10am Ate toast prior to the first dose. I never thought how much this trial would affect me mentally. So many thoughts and emotions to deal with. It’s lovely to have so many supporters. What’s more is, the support is worldwide. I’m overwhelmed.
9:25am I’m staring at the new drug! Holding back tears here.
9:30am Final checks are being made prior to the first dose.
9:35am I’ve seen the tablet. It’s a capsule. Looks like the blood-red capsules similar to Rifampicin, but probably same size as Creon.
The nurses are counting the capsules to make sure all is present and correct.
9:45am The first dose is taken. I’m cured…or am I? Placebo or not placebo, that is the question.
10:00am A first blood sample is taken.
10:15am A second blood sample is taken.
10:30am Blood pressure and pulse rate is taken.
10:40am ECG is done.
10:45am A blood sample is taken.
11:10am I’ve lost count to how many people are following me today. This has gone viral in the USA and Australia as well as the UK.
11:30am Blood pressure and pulse rate is taken.
11:40am ECG and blood sample were taken.
12:00pm Lunchtime…chicken roast. Mmmm!
12:45pm A blood sample is taken.
1:30pm Blood pressure and pulse rate is taken.
1:40pm A blood sample is taken.
1:45pm A urine sample is taken and physical examination done.
I woke up at 5:40am to the alarm of a clock coming from within a dream I was having. Typical. 20 minutes before my real alarm clock was due.
Ah well, at least I was up early and not late…that would’ve been another story.
I quickly showered and freshened myself up ready for the big day.
Clothes were laid out ready and a quick look in the mirror at me, as I am now before I set off to a new life.
I left the house in a dark neighbourhood. Everyone still sleeping as I got in my car and silently left the area to the Medical Research Unit at Wythenshawe.
As I joined the network of traffic on the M6, I compared the motorway to an artery, it’s travellers as the blood cells giving life to the island on which we live, which ironically is shaped like a begging dog.
I listened to an assortment of TV themes I downloaded. All of which I found symbolic to this day.
As I drove to Wythenshawe, I watched the sky turn from black to purple to blue. A new dawn, a new day, a new life (must write a song about that).
I parked outside the centre and entered the building which would help set a new life for the CF world.
As the staff were setting up to start today’s tests, I was informed I’m the only CF person in the world on this drug trial at present.
I was told the recruiting for this trial is ongoing for taking on more CF volunteers, so WATCH THIS SPACE!
Here is an account of what happened today:
7:30am Completed “Quality of Life” questionnaire.
7:50am Weight 66.7kg (gained 0.9kg since the last visit). Temperature and blood pressure are taken.
8:15am ECG is done.
8:30am A urine sample is taken – they’re always taking the piss! LOL
9:00am I did the breathing tests again.
On this occasion towards the end of the first test, my mouth opened slightly after being told not to release my lips from the mouthpiece. Had to repeat the test. Oops!
Though I passed the test – I can breathe! LOL
10:20am Lung function FEV1 2.08; FVC 4.51
10:30am Sweat chloride test. The sensation feels like pins and needles.
11:30am Sweat test complete.
11:45am Bloods taken…took 4 attempts. Ouch!
12:54pm All done for the day. Having lunch and then going home.
Since the announcement was made that I’d be taking part in this drug trial, I’ve had many interest from many people.
It’s strange really. I expected there to be interest from other people in regards to this trial, but I suppose I didn’t realise how big the interest would be.
I was asked the other day how do you feel about taking part in this drug? An answer to which came about whilst I was at work having a quiet moment as I went about my duties.
I’m going through all sorts of emotions.
There’s so much to take in and accept at present.
Since birth, I’ve been used to my condition and over the years I’ve heard in the media of many breakthroughs towards a cure to CF. Most of which were, well, not utter rubbish, but signs of a better understanding of what makes CF tick, which would benefit the progression of finding better treatments.
I didn’t really know this type of treatment would become a reality in my lifetime. I thought I’d be dead well before something like this would come to life.
How wrong was I?
I said before there are eyes watching my every move on Facebook waiting for a new blog to be written.
There are CF people out there who are on the edge of their seats as they wait for me to write the blog longed to be seen…what effects am I feeling from taking this miracle drug?
Even I feel teased by this question. I don’t even know if I will have the actual drug or a placebo. No one will know if I’ve had the drug until the trial is complete.
The only answer I will be able to give is, basically, let’s see what happens.
Will I feel any effects?
Will I be on the placebo and any the effects would be by sheer cruel coincidence and all psychological?
Will the effects be due to me being on the actual drug?
What if nothing happens at all?
Many questions…all of which I’m having to keep myself busy so not to think about any of this.
With people at work when I’ve finished my shift at 2pm, if my best mate is available, I’d give him a call or Facetime and talk about anything just so my mind is focused on something other than wondering the answers to the questions above.
Don’t get me wrong, I am excited about this life long wait of a drug that will make living with CF a lot easier.
I simply want everything to go really well and for this trial to result in many, who like me, have waited since they were born for a drug like this to be available on the market so we can all breath easy.
In the meantime, all I can leave you with for now is in 36 hours time, I will probably be taking the first dose of QBW251.